EXHIBIT 10.40
PORTIONS OF THIS DOCUMENT HAVE BEEN OMITTED (DESIGNATED BY AN
ASTERIX (*) AND WHITE SPACE) AND FILED SEPARATELY WITH
THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A
REQUEST FOR CONFIDENTIAL TREATMENT DATED
AUGUST 21, 1997; FILE NO. 0-15609
VIRACEPT
(NELFINAVIR MESYLATE)
LICENSE AGREEMENT
BETWEEN
AGOURON PHARMACEUTICALS, INC. AND JAPAN TOBACCO INC.
AND
▇. ▇▇▇▇▇▇▇▇-▇▇ ▇▇▇▇▇ LTD
June 30, 1997
TABLE OF CONTENTS
Page No.
BACKGROUND .........................................................................................1
ARTICLE I DEFINITIONS..............................................................................2
Section 1.01 Affiliate................................................................................2
Section 1.02 Agouron/JT Patent Rights.................................................................2
Section 1.03 Agouron/JT Technology....................................................................2
Section 1.04 Combination Product......................................................................2
Section 1.05 Compound.................................................................................3
Section 1.06 Control, Controlled or Controlling.......................................................3
Section 1.07 D&L Agreement............................................................................3
Section 1.08 Development Program......................................................................3
Section 1.09 Development Program Patent Rights........................................................3
Section 1.10 Development Program Technology...........................................................4
Section 1.11 Dossier..................................................................................4
Section 1.12 Effective Date...........................................................................4
Section 1.13 EMEA.....................................................................................4
Section 1.14 Field....................................................................................4
Section 1.15 Initial Commercial Sale..................................................................4
Section 1.16 Licensed Territory and Asian Licensed Territory..........................................4
Section 1.17 MAA......................................................................................5
Section 1.18 Major European Country...................................................................5
Section 1.19 Net Sales................................................................................5
(a) Adjusted Gross Sales..............................................................5
(b) Net Sales.........................................................................5
Section 1.20 Patent Rights............................................................................5
Section 1.21 Product..................................................................................5
Section 1.22 Registration.............................................................................5
Section 1.23 Roche Technology.........................................................................6
Section 1.24 Territory................................................................................6
Section 1.25 Trade Dress..............................................................................6
Section 1.26 Trademark(s).............................................................................6
ARTICLE II COMMERCIAL RIGHTS........................................................................6
Section 2.01 License Grants...........................................................................6
Section 2.02 Indications of the Compound and/or Products Outside of the Field.........................8
Section 2.03 Diligent Efforts to Market...............................................................8
Section 2.04 Discontinuance of the Development Program................................................9
i
Page No.
ARTICLE III SHARING AND PROTECTION OF INTELLECTUAL PROPERTY.........................................10
Section 3.01 Patents.................................................................................10
Section 3.02 Infringement of Patents of Third Parties................................................13
Section 3.03 Trademarks..............................................................................15
Section 3.04 Information Exchange....................................................................15
Section 3.05 Confidentiality.........................................................................16
Section 3.06 Publication.............................................................................17
ARTICLE IV MANAGEMENT STRUCTURE OF COLLABORATION...................................................18
Section 4.01 Coordination..............................................................................
Section 4.02 Development and Registration; Responsibility for Development Costs......................18
Section 4.03 Marketing...............................................................................20
Section 4.04 Supply of Product.......................................................................22
ARTICLE V LICENSE FEES AND ROYALTIES; GENERAL LICENSING TERMS 25
Section 5.01 License Fees and Royalties..............................................................25
Section 5.02 General Licensing Terms.................................................................28
Section 5.03 Foreign Currency........................................................................32
ARTICLE VI TERM AND TERMINATION....................................................................33
Section 6.01 Termination for Breach..................................................................33
Section 6.02 Termination by Roche....................................................................33
Section 6.03 Termination by Mutual Agreement.........................................................35
Section 6.04 Termination Upon Bankruptcy.............................................................35
Section 6.05 Disposition of Inventory................................................................35
Section 6.06 Effect of Termination...................................................................35
ARTICLE VII WARRANTIES, COVENANTS; INDEMNITIES; INSURANCE; DISPUTE RESOLUTION; GOVERNMENTAL
APPROVALS; EXPORT CONTROLS..............................................................36
Section 7.01 Warranties and Covenants................................................................36
Section 7.02 Indemnities; Insurance..................................................................36
Section 7.03 Dispute Resolution......................................................................38
Section 7.04 Governmental Approvals..................................................................39
Section 7.05 U.S. Export Controls....................................................................39
ARTICLE VIII DISCLOSURE OF AGREEMENT.................................................................39
Section 8.01 Disclosure of Agreement.................................................................39
ii
ARTICLE IX GENERAL PROVISIONS......................................................................40
Section 9.01 No Implied Licenses.....................................................................40
Section 9.02 No Waiver...............................................................................40
Section 9.03 Severability; Government Acts...........................................................40
Section 9.04 Ambiguities.............................................................................40
Section 9.05 Notification of Authorities.............................................................40
Section 9.06 No Agency...............................................................................40
Section 9.07 Captions; Number; Official Language.....................................................41
Section 9.08 Force Majeure...........................................................................41
Section 9.09 Amendment...............................................................................41
Section 9.10 Applicable Law..........................................................................41
Section 9.11 Notices.................................................................................42
Section 9.12 Assignment..............................................................................42
Section 9.13 Succession..............................................................................42
APPENDICES
Schedule 1 Agouron/JT Patent Rights S1-1
Schedule 2 Asian Licensed Territory S2-1
Schedule 3 Nelfinavir Mesylate Clinical Studies S3-1
Results to be Contained in the MAA S3-1
Interim Results to be Contained in the MAA S3-2
Results to be Provided Later S3-3
Attachment 1 Trademark License A1-1
Attachment 2 Product Manufacturing Specifications A2-1
iii
This VIRACEPT(TM)1 (nelfinavir mesylate) License Agreement
("Agreement"), dated for reference purposes only this 30th day of June 1997, is
by and among Agouron Pharmaceuticals, Inc., a corporation duly organized and
existing under the laws of the state of California, having a principal place of
business at ▇▇▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇ ▇▇▇▇, ▇▇ ▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇ ▇▇▇▇▇▇
of America (hereinafter referred to as "Agouron"), Japan Tobacco Inc., a
corporation duly organized and existing under the laws of Japan, having its
principal place of business at JT ▇▇▇▇▇▇▇▇, ▇-▇, ▇▇▇▇▇▇▇▇▇ ▇-▇▇▇▇▇, ▇▇▇▇▇▇-▇▇,
▇▇▇▇▇, ▇▇▇▇▇ (hereinafter referred to as "JT"), and ▇. ▇▇▇▇▇▇▇▇-▇▇ ▇▇▇▇▇ Ltd, a
corporation duly organized and existing under the laws of Switzerland, having
its principal place of business at ▇▇-▇▇▇▇-▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇▇ (hereinafter
referred to as "Roche"). Agouron, JT and Roche are each sometimes hereinafter
referred to as a party (collectively "parties") to this Agreement.
BACKGROUND
On December 1, 1994, Agouron and JT entered into a Development and
License Agreement ("D&L Agreement") under which they have collaborated in the
development and commercialization of the chemical compound known as "nelfinavir
mesylate" (sometimes referred to herein as "VIRACEPT") to treat and prevent
Human Immunodeficiency Virus infections.
On January 17, 1997, Agouron, JT and Roche entered into a Letter of
Intent ("LOI") pursuant to which Agouron and JT granted a license to Roche to
sell nelfinavir mesylate products to treat and prevent Human Immunodeficiency
Virus infections in certain countries of the world on terms substantially in
accordance with those contained in Exhibit A to the LOI ("Exhibit A"). While
Exhibit A states the basic terms of the understanding between the parties, the
parties agreed that the full license terms would be subject to further
negotiation and preparation of a further agreement containing the full terms of
the license between the parties. This Agreement is entered into for the purpose
of setting forth the definitive terms under which Roche is licensed to sell
nelfinavir mesylate products to treat and prevent Human Immunodeficiency Virus
infections in certain countries of the world.
NOW, THEREFORE, in consideration of the premises, and the mutual
covenants, benefits and obligations set forth herein, the parties agree as
follows:
--------
1 VIRACEPT is a trademark of Agouron Pharmaceuticals, Inc., and is registered in
the United States and in certain other countries.
1
ARTICLE I - DEFINITIONS
When used in this Agreement, each of the following terms shall have the
meanings set out in this Article I. All references to Articles, Attachments,
Sections and Schedules shall, except as otherwise explicitly provided, refer to
the Articles, Attachments, Sections and Schedules of this Agreement, all of
which are incorporated herein by reference.
Section 1.01 "Affiliate" means any person, organization or entity which
is, directly or indirectly, controlling, controlled by, or under common control
with Roche, Agouron or JT, as the case may be. The term "control" (including,
with correlative meaning, the terms "controlled by" and "under common control
with"), as used with respect to any person or entity, means the possession,
directly or indirectly, of the power to direct, or cause the direction of, the
management and policies of such person, organization or entity, whether through
the ownership of voting securities, or by contract or court order or otherwise.
The ownership of voting securities of a person, organization or entity shall
not, in and of itself, constitute "control" for purposes of this definition,
unless said ownership is of a majority of the outstanding securities entitled to
vote of such a person, organization or entity. For purposes of this Agreement,
Genentech, Inc. shall be considered to be an Affiliate of Roche, and the
government of Japan shall not be considered to be an Affiliate of JT.
Section 1.02 "Agouron/JT Patent Rights" means: *
Section 1.03 "Agouron/JT Technology" *
Section 1.04 "Combination Product" means *
2
Section 1.05 "Compound" means the chemical compound known as
nelfinavir mesylate whose chemical name is as follows:
[3S-(3R*, 4aR*, 8aR*, 2'S*, 3'S*)]-2-[2'-hydroxy-3'-phenylthiomethyl-
4'-aza-5'-oxo-5'-(2"-methyl-3"-hydroxyphenyl)pentyl]-
decahydroisoquinoline-3-N-t-butyl carboxamide methanesulfonic acid
salt
and whose chemical structure is as follows:
[GRAPHIC OMITTED]
Section 1.06 "Control," "Controlled" or "Controlling" *
Section 1.07 "D&L Agreement" means the December 1, 1994
Development and License Agreement between Agouron and JT, as amended.
Section 1.08 "Development Program" *
Section 1.09 "Development Program Patent Rights" *
3
Section 1.10 "Development Program Technology" *
Section 1.11 "Dossier" means the document which is filed with and
approved by a government or health authority for purposes of Registration, for
example, a Marketing Authorization Application.
Section 1.12 "Effective Date" means January 17, 1997.
Section 1.13 "EMEA" means the European Agency for the Evaluation of
Medicinal Products.
Section 1.14 "Field" means the treatment and prevention of Human
Immunodeficiency Virus ("HIV") infections.
Section 1.15 "Initial Commercial Sale" means the first commercial
sale of a Product in the Field *
Section 1.16 "Licensed Territory" and "Asian Licensed Territory" shall
have the following meanings:
4
(a) "Licensed Territory" means all countries of the world (including
all countries included in the "Asian Licensed Territory" as defined below),
except for the United States (and its territories, possessions and protectorates
(including Puerto Rico), and the District of Columbia), Canada, Mexico, Japan
(other than those areas in Japan in which Roche is granted and accepts the
commercialization rights described in Schedule 2), South Korea and North Korea.
(b) "Asian Licensed Territory" means all the countries of Asia
listed on Schedule 2.
Section 1.17 "MAA" means Marketing Authorization Application
Section 1.18 "Major European Country" means *
Section 1.19 "Net Sales" and the related term "Adjusted Gross Sales"
shall have the following meanings:
(a) "Adjusted Gross Sales" means *
(b) "Net Sales" means *
Section 1.20 "Patent Rights" means, collectively, *
Section 1.21 "Product" means *
Section 1.22 "Registration" means the official approval by the
government or health authority in a country (or supra-national organizations,
such as the European Agency for the Evaluation of Medical Products) which is
required for a Product to be offered for sale in such country, including such
authorizations as may be required for the production, importation,
5
pricing, reimbursement and sale of such Product, and for subsequent regulatory
filings for line extensions and/or additional indications of such Product.
Section 1.23 "Roche Technology" means *
Section 1.24 "Territory" means *
Section 1.25 "Trade Dress" means any materials supporting the
commercialization of a Product, including, but not limited to, packaging,
package inserts, advertising or selling aids, brochures, mailings and/or other
marketing or packaging materials.
Section 1.26 "Trademark(s)" means any trademark selected and owned by a
party and registered (or applied for) by such party, its Affiliate(s) and
sublicensee(s) in the Territory for use in connection with the marketing of
Products. The definition of Trademark(s) shall not refer to trade names used by
a party to designate the name of such party.
ARTICLE II - COMMERCIAL RIGHTS
Section 2.01 License Grants. To implement the commercialization of the
Compound and/or Products arising out of the Development Program, the parties,
subject to the other applicable obligations of this Agreement, grant and accept
the license rights provided below in this Article II.
(a) *
(b) *
6
(c) *
(d) *
(e) *
(f) *
(g) *
(h) *
7
(i) *
(j) *
Section 2.02 Indications of the Compound and/or Products Outside of the
Field.
(a) Subject to the provisions of the D&L Agreement, except as provided
in Section 2.02(b), Agouron and JT, in their sole discretion, shall be entitled
to make, use, develop and commercialize the Compound and/or Products for
indications outside of the Field in the Territory.
(b) *
Section 2.03 Diligent Efforts to Market. As provided below, the
right of Roche to market Products in the Field in a country located in the
Licensed Territory shall be subject to diligent marketing efforts by Roche. *
Roche, using diligent
marketing efforts, agrees to provide sales and other promotional support *
that is equivalent to or greater than that which Roche, its Affiliates
and/or sublicensees are then providing for saquinavir in such country. After
such * Roche shall provide a reasonable level of sales and other promotional
support for a Product in a country which, when measured as
8
a percentage of Adjusted Gross Sales of such Product in such country, is
equivalent to or greater than that which Roche, its Affiliates and/or
sublicensees are then providing *
If, after * written
notice of the failure by Roche to provide the agreed upon level of sales
and other promotional support for a Product in a country located in the Licensed
Territory, Roche fails to fulfill its obligation under this Section 2.03,
Agouron and JT shall have the right, *
Section 2.04 Discontinuance of the Development Program.
(a) Roche shall, in a timely manner, use reasonable diligence in
the development and Registration of a Product in the Field in the countries of
the Licensed Territory. *
If, after *
written notice of the failure by Roche
to use reasonable diligence, in a timely manner, in the development and
Registration of a Product in the Field in a country located in the Licensed
Territory, Roche fails to fulfill its obligations under this Section 2.04(a),
such failure shall be deemed to be an election by Roche *
9
(b) *
ARTICLE III - SHARING AND PROTECTION OF INTELLECTUAL PROPERTY
Section 3.01 Patents.
(a) *
10
(i) *
(ii) *
(iii) *
(iv) Notwithstanding the preceding, *
11
(b) The preparation, filing, prosecution, maintenance and extension of
patent applications and issued patents included within the Agouron/JT Patent
Rights shall be conducted in accordance with and governed by the provisions of
the D&L Agreement; provided, however, that an *
Ownership
of the Agouron/JT Patent Rights shall be determined in accordance with the
provisions of the D&L Agreement; provided, however, that the parties hereby
acknowledge that, in accordance with the provisions of *
(including expenses for
the preparation, filing, prosecution and maintenance of patent term restoration
applications and supplemental protection certificates, but excluding any travel
expenses of the parties, which shall be borne by the party incurring such
expenses).
(c) A representative of Roche and an authorized representative of
Agouron and JT shall *
to review and discuss the actions taken or to be taken by each of the parties
in protecting the commercial interests of the parties in Development Program
Patent Rights. Such meetings may be conducted in person or by means of telephone
conference calls. Each party shall pay its own costs of participating in such
meetings. Prior to or immediately after the filing of the initial patent
application for an invention, the filing party shall provide the authorized
representatives of the other parties with an English language version of the
patent application for the non-filing parties' review and comment. If requested
by a non-filing party, the filing party shall also provide such non-filing party
with a full copy of each patent application actually filed in English and in the
language in which it was originally filed. It is the intent of the parties that
any patent issuing to the parties hereunder shall be of the same quality and
scope that the party would have sought with respect to its other valuable
proprietary property not subject to this Agreement. Each of the parties shall
annually prepare a list which reflects, to the best of its knowledge, the
current status of any Development Program Patent Rights for which it controls
the preparation, filing, prosecution, maintenance and/or extension of the patent
applications and issued patents, which list shall be submitted to the other
parties within sixty (60) days after the end of the calendar year. An authorized
representative of Agouron and JT shall annually prepare a list which reflects,
to the best of their knowledge, the current status of the Agouron/JT Patent
Rights. For purposes of this Section 3.01, Agouron and JT shall be deemed to be
a single party. The parties, if they so elect, may mutually prepare a joint list
to satisfy the preceding obligations.
12
(d) *
(e) *
(f) *
Section 3.02 Infringement of Patents of Third Parties.
(a) Each party, its Affiliates and sublicensees, and their respective
employees and agents shall use diligent efforts to avoid infringement of patents
of any third party in discovering, developing, manufacturing and commercializing
the Compound, intermediates thereof and/or Products. However, a party, its
Affiliates and sublicensees, and their respective employees and agents shall not
be liable to another party, its Affiliates and sublicensees, and their
respective employees and agents if the practice of the Patent Rights, Agouron/JT
Technology, Roche
13
Technology, and/or Development Program Technology in discovering, developing,
manufacturing or commercializing the Compound, intermediates thereof and/or
Products infringe any patent of any third party. If a party becomes aware of any
claim or suit by any third party for infringement of a patent of such third
party in connection with the discovery, development, manufacture, use or sale of
the Compound, intermediates thereof and/or Products by a party hereto, such
party shall notify the other parties in writing of such claim or suit within
thirty (30) days thereafter. Each party agrees to render such reasonable
assistance as the other party(s) may request in defending any such claim or
suit. The parties shall mutually agree to any settlement of any existing or
potential infringement claim or action that would require the payment of any
royalty or lump sum payment to a third party, except that if the parties cannot
promptly reach agreement, they shall appoint an independent patent counsel to
give an opinion, which shall be binding on the parties, as to whether there is a
substantial risk that the third party patent is both valid and infringed. If the
opinion is that there is a substantial risk that the patent is both valid and
infringed, the marketing party of a Product in a country, after consultation
with the other parties, may settle the matter in its sole discretion on such
terms as it deems appropriate. If more than one party is participating in the
marketing of a Product in a country, the marketing parties shall mutually agree
to any settlement of any infringement claim or action that would require the
payment of any royalty or lump sum payment to a third party; if the parties are
unable to mutually agree on the settlement, then the issue shall be decided by
binding arbitration in accordance with the provisions of Section 7.03 hereof.
(b) *
The parties acknowledge that the manufacture and/or use
of certain materials or processes used in the manufacture of the Product *
(iii) that the provisions of this Section
3.02 do not apply to *
If royalties to third parties are due
because of the manufacture and/or use of certain materials or processes used in
the manufacture of the Product and such royalties are measured by Roche's Net
Sales of such Product, then such royalties shall not be payable by Roche prior
to the date of sale of such Product. The parties further specifically
acknowledge that license fees and/or royalties may be owed to third parties *
Notwithstanding the preceding, *
14
which are then being commercially
used in the manufacture of the Product, the parties shall discuss in good
faith the sharing of such costs as provided above, versus changing the method of
manufacture of the Product.
Section 3.03 Trademarks. A party, its Affiliates and sublicensees,
if any, *
it is the intent
of the parties that a single Trademark be identified and developed for use in
connection with marketing of Products in the Field wherever possible throughout
the Territory. The parties acknowledge that, while Agouron has already selected,
filed and owns the VIRACEPT Trademark application and/or Trademark in certain
countries of the Territory, it is nevertheless their intention to use the
VIRACEPT Trademark in connection with the marketing of Products in the Field
wherever possible. If required by the laws of a specific country, the party
owning the Trademark shall assist the other party(s) in qualifying as a
registered user of such Trademark in such country. *
Additionally, the parties agree to cooperate with the other parties
in reasonable efforts to protect the rights of the parties in a Trademark,
including notification of any infringement which may come to a party's
attention, and the proper execution and filing of appropriate registered user
documents. *
Section 3.04 Information Exchange. *
15
Section 3.05 Confidentiality. Except as otherwise expressly specified
in this Agreement and except for the proper exercise of any license rights
granted or rights reserved under this Agreement, Roche, Agouron and JT shall
each keep in confidence and shall each use its best efforts to cause its
respective Affiliates, employees, directors, agents, consultants, clinical
research associates, outside contractors, clinical investigators and
sublicensees to whom it is permitted to disclose information pursuant to the
terms of this Agreement to retain in confidence: (i) all confidential and
proprietary information of the other party, including *
and/or the marketing
and business plans of such other party that is disclosed to it hereunder; and
(ii) Development Program Technology. Without limiting the foregoing, Roche,
Agouron and JT shall each exercise the same degree of diligence and care with
respect to the above-described information as it exercises with respect to its
other proprietary information. Each party represents to the other parties that
it maintains policies and procedures designed to prevent the unauthorized
disclosure of its proprietary data and information. Roche further agrees that it
shall: (i) limit dissemination of and access to the confidential and proprietary
information of Agouron and JT within Roche's organization to those of Roche and
its Affiliates' personnel who have a need to know the information; and (ii) not
disclose such confidential and proprietary information to any employees of any
of its Affiliates if such Affiliate is doing business in a country not included
in the Licensed Territory, unless an authorized representative of Agouron and JT
specifically authorizes in writing such disclosure, and the employees of the
Affiliate receiving such information agree in writing not to disclose or use any
such information disclosed to them other than for the performance of this
Agreement and the proper exercise of any license rights granted to Roche.
Agouron and JT agree to limit dissemination of and access to confidential and
proprietary information of Roche concerning INVIRASE to Agouron and JT
personnel, and their respective Affiliates' personnel, who have a need to know
the information. Roche, Agouron and JT shall each be entitled to disclose the
above-described information to its consultants, clinical research associates,
outside contractors, collaborators, clinical investigators and other third
parties who are subject to confidentiality and use obligations equivalent to
those applicable to the disclosing party hereunder, and to governmental or other
regulatory and/or health authorities, to the extent that such disclosure is
reasonably necessary to obtain patents, to obtain authorization or to conduct
clinical trials on the Compound or Products, to prepare the Dossier, and/or
otherwise to fulfill its obligations pursuant to this Agreement. An authorized
representative of Agouron and JT shall be responsible, in its sole discretion,
for authorizing the supply of any drug samples of the Compound and/or Products
to third party researchers. Roche, Agouron and JT shall each have the right to
disclose Development Program Technology to persons it proposes to enter into
business relationships with, if such persons are subject to confidentiality
obligations equivalent to those applicable to the disclosing party hereunder.
The preceding obligations of confidentiality shall be waived as to information
which the party claiming waiver can demonstrate, based on written records: (i)
is in the public domain at the time of disclosure hereunder; (ii) comes into the
public domain through no fault of the party claiming waiver; (iii) was known to
the party claiming waiver prior to its disclosure under this Agreement, unless
such information was obtained from the other
16
party on a confidential basis; (iv) is disclosed on a non-confidential basis to
the party claiming waiver by a third party having a lawful right to make such
disclosure on a non-confidential basis; (v) is published with the prior mutual
agreement of the parties after having given consideration to appropriate
commercial factors; (vi) comes into the public domain through governmental
publication of a patent application; or (vii) is required to be disclosed to
file a patent or other regulatory application, or to comply with applicable laws
and regulations. The obligations under this Section 3.05 shall survive to the
later of: (i) * after the end of the Development Program; or
(ii) the termination or expiration date of the last to expire of any license(s)
granted pursuant to this Agreement, to the extent the Development Program
Technology, Agouron/JT Technology or Roche Technology is applicable to the
practice of grants under such license(s); or (iii) the expiration date of the
last to expire of any patent(s) within the Patent Rights on a Product.
Section 3.06 Publication. Agouron, JT and Roche each acknowledges the
interests of the other parties in publishing certain of their results of the
development and Registration of a Product to obtain recognition within the
scientific community and to advance the state of scientific knowledge. The
parties also recognize their mutual interests in obtaining valid patent
protection for their drug products. Consequently, a party, its employees or
consultants *
Furthermore, in acknowledgment that certain *
the parties agree that each party shall *
After
giving reasonable consideration to the suggestions of the
objecting party, the party wishing to *
Each
party will use its reasonable efforts to inform the other parties about proposed
oral presentations which such party intends to make, if it will be disclosing
new scientifically significant data concerning the Product at the oral
presentation.
17
ARTICLE IV - MANAGEMENT STRUCTURE OF COLLABORATION
Section 4.01 Coordination. Coordination of the parties' development and
commercialization efforts for the Compound and Products in the Field in the
Licensed Territory shall be carried out as specified in Sections 4.02 and 4.03.
Section 4.02 Development and Registration; Responsibility for
Development Costs. Roche, Agouron and JT acknowledge their mutual intention to
cooperate in a commercially reasonable approach in the timely development of the
Compound and Products in the Field in the Licensed Territory. The parties
further acknowledge their mutual willingness to discuss ad hoc agreements to
establish appropriate mechanisms for such cooperation. Recognizing the
importance of timely initiation of development activities, however, Roche,
Agouron and JT agree to the following basic approach to development of Products
in the Field in the Licensed Territory, and to the conduct and funding of their
respective development activities.
(a) Except as otherwise agreed to by the parties, Agouron and JT shall
be responsible for completing, in a reasonable manner, and funding the studies
* these studies include the core development program studies
designed to achieve Registration of Products in the Field in the major countries
of the Licensed Territory. The parties acknowledge that Agouron and JT, despite
reasonable diligence, may be unable to complete *
(b) In collaboration with Roche, Agouron shall be responsible *
and
shall have the primary responsibility for the *
for the
ongoing correspondence and interaction concerning such Product with the
applicable regulatory authorities of the European Union. Roche shall be
responsible for negotiating pricing and reimbursement for a Product with the
regulatory authorities of the European Union.
(c) * shall be responsible for making in a timely manner
any alterations to the
* which are required for *
18
Except as otherwise agreed to by the
parties, Roche shall be responsible for *
(d) Roche shall be responsible for *
(other than those * ) which involve *
). Roche shall be responsible for the *
(e) Subject to the availability of adequate drug supply of Product,
Roche shall be responsible for the cost and implementation (possibly in
cooperation with a previously contracted contract research organization) of an
expanded access program for Products in appropriate countries of the Licensed
Territory, including specifically the countries located in Europe, Australia,
New Zealand and Brazil, which expanded access program shall be consistent in
scope with the expanded access program implemented by Agouron in North America.
Agouron and JT will reasonably consider Roche's request to conduct a portion of
the expanded access program as a program involving special license sales, if
such request does not interfere with the parties relationship with the HIV
community and/or government authorities and does not require a change in the
formulation (clinical versus commercial formulations) of drug product otherwise
allocated to the expanded access program.
(f) *
(g) Each party shall be entitled to have the government or health
authorities cross-reference information contained in any Dossier for a Product
filed in any country in the Territory, as may be necessary to obtain and
maintain the Registration on a Product in any other country in the Territory.
(h) Each party agrees to use its diligent efforts in responding in a
timely manner, but not more than thirty (30) days, to requests from the other
party for preclinical and clinical results and other information concerning the
Development Program to enable the other party to comply with regulatory
requirements for the Development Program. To the extent possible, the parties
19
shall develop and use compatible reporting forms in the clinical studies aimed
at achieving Registration of Products in the Field. A party conducting a study
involving the Product shall assist the other parties in the incorporation of the
data from such study into their Dossiers, if necessary.
(i) Roche shall keep Agouron and JT informed of its progress in the
development and Registration of Products. This shall include, * regular
meetings of the parties, and such written progress reports as are agreed to by
the parties which summarize Roche's activities during each reporting period and
Roche's planned activities for the succeeding period. The meeting locations of
the parties shall be at sites agreed to by the parties. Meeting minutes shall be
promptly prepared and approved by designated representatives of each of the
parties. Each party shall pay all of its respective expenses for such meetings.
Agouron and JT shall keep Roche informed of their development and Registration
activities to the extent that such development and Registration activities are
relevant to the development and Registration of Products by Roche in the
Licensed Territory. Each of the parties shall *
each
representative shall report to his/her management on the matters discussed at
each of the meetings of the parties. Each party, prior to its implementation
of a *
shall use its
reasonable efforts to provide the other parties with a copy of the *
manner, but not more than thirty (30) days, *
Roche agrees to use its
diligent efforts in responding in a timely manner, but not more than *
to requests from Agouron or JT for information *
(j) Roche, Agouron and JT shall each use qualified persons in the
development activities of the Development Program.
(k) All work in connection with the development of the Compound or
Products, to the extent required by applicable laws or regulations, shall be
conducted in accordance with Good Laboratory Practices, Good Manufacturing
Practices and Good Clinical Practices, as such rules of practice are amended
from time to time.
(l) If a party is conducting a study in a country located in another
party's marketing territory, the party conducting the study shall use its best
efforts to avoid interfering with such other party's activities in such country.
Section 4.03 Marketing. Roche shall be responsible for the marketing of
Products in the Field in the Licensed Territory. Roche, Agouron and JT agree to
the following basic approach to the marketing of Products in the Field in the
Licensed Territory and to the conduct of their respective marketing activities.
20
(a) *
Roche
shall modify the * only to the extent required to respond to
country-specific needs, and implement *
Agouron, JT and their licensees *
(b) Roche shall be responsible for distribution of a Product in any
countries located in the Licensed Territory where Roche is exclusively marketing
such Product in the Field.
(c) Roche shall keep Agouron and JT informed of Roche's *
This shall include, *
the regular meetings of the parties, and such written progress reports as
are agreed to by the parties which summarize Roche's activities during each
reporting period and Roche's planned activities for Products for the succeeding
period. The meeting locations of the parties shall be at sites agreed to by the
parties. Meeting minutes shall be promptly prepared and approved by the
designated representatives of each of the parties. Each of the parties shall pay
all of its respective expenses for such meetings. Each of the parties shall *
each representative shall report to his/her
management on the matters discussed at the meetings of the parties. At the
meetings of the parties, the representatives of the parties shall review and
discuss *
(d) It is the intent of the parties that the VIRACEPT Trademark be
identified and developed for use in connection with the marketing of Products in
the Field wherever possible throughout the Territory. Unless otherwise agreed
and as permitted by law, Roche agrees to market Products in the Field under the
VIRACEPT brand name in all countries in the Licensed Territory. The parties also
acknowledge their intention to use, if appropriate, the same Trade Dress in
connection with the marketing of Products in the Field wherever possible.
(e) In countries where Roche is exclusively marketing a Product in the
Field, unless prohibited by law or regulation, the labeling for such Product
shall state that the Product is licensed from Agouron and JT, and indicate that
the Product is a product of the joint development of Agouron, JT and Roche. To
the extent required to comply with the provisions of this Section 4.03(e), each
party grants to the other parties the right to use its name and logos in the
labeling for a Product.
21
(f) Roche shall use qualified persons in its marketing activities
for a Product in a country located in the Licensed Territory.
(g) Roche shall be responsible for responding, in a timely manner, to
inquiries and for reporting adverse drug reactions related to a Product in a
country located in the Licensed Territory after the Product is on the market in
the Field in such country. Notwithstanding Roche's ultimate responsibility for
the professional services and the health and/or regulatory authorities'
communications related to a Product after such Product is on the market in the
Field in a country located in the Licensed Territory, to the extent reasonably
possible, Agouron and JT shall have the right to review, comment and participate
in communications concerning such Product with the health and/or regulatory
authorities in such country. Furthermore, Roche, Agouron and JT shall each be
entitled to respond to routine medical questions or inquiries directed to them.
Each party shall use its best efforts to provide the other parties with all
information reasonably necessary to respond properly and promptly to any such
questions or inquiries; the parties shall also use their best efforts to keep
such information current. Without limiting the foregoing, Roche, Agouron and JT
*
The parties shall confer with respect to responding to anticipated inquiries and
questions. Each party shall use its best efforts to promptly provide the other
parties with new information, scientific findings, and summaries of regulatory
or judicial requests specifically related to a Product, to the extent that such
information, findings or requests are likely to have a significant impact on the
other parties' marketing of such Product.
Section 4.04 Supply of Product.
(a) Roche shall purchase from Agouron and/or JT, and Agouron and/or JT,
subject to the provisions of Section 4.04(c), shall use their reasonable efforts
to deliver, the finished dosage form(s) of Product *
22
(b) Roche shall purchase from Agouron and/or JT and Agouron and/or JT,
subject to the provisions of Section 4.04(c), shall use their reasonable efforts
to deliver, the finished dosage form(s) of Product, for sale in the Licensed
Territory, including special license sales, *
(c) Agouron and JT shall maintain books of account and complete
and accurate records of all of their *
(d) *
23
(e) Roche shall assist Agouron and JT in the identification of low-cost
manufacturing sources for a Product. Roche shall also provide without charge, to
the extent available, technical and manufacturing assistance and use of its
technology and proprietary information to Agouron and JT in an effort to
decrease the production costs of such Product.
(f) Agouron and JT agree to discuss in good faith with Roche an
arrangement under which Roche could be the manufacturer of a Product to be used
in the Licensed Territory, including the prerequisite requirement that *
(g) All Product is to be manufactured in accordance with the
specifications to be determined during development and later attached hereto in
Attachment 2 to this Agreement and any amendments thereto. All Product shall be
furnished with a certificate of analysis.
(h) Roche shall grant to both Agouron and JT a right of reference to
the drug master file for a Product in the countries where Roche, its Affiliates
or sublicensees are marketing such Product, and shall take all other steps as
may be reasonably requested by a manufacturer of such Product for the limited
purpose of enabling it to manufacture the Product for Roche, its Affiliates or
sublicensees. The manufacturer shall manufacture a Product in compliance with
the Dossier for such Product. Each party shall promptly and fully advise the
other parties of any changes, alterations or amendments to the drug master file
for a Product, or any amendments, instructions or specifications required by the
health or regulatory authority, and the parties shall confer with respect to the
best mode of compliance with any such requirements.
(i) In the event any Product delivered hereunder must be recalled
because of action by the relevant health authority, the parties shall cooperate
fully with each other in conducting such recall to the full extent necessary to
ensure that the recall is effective. Any recall expenses for such Product in a
country located in the Licensed Territory shall be the responsibility of the
party marketing the Product.
24
ARTICLE V - LICENSE FEES AND ROYALTIES;
GENERAL LICENSING TERMS
Section 5.01 License Fees and Royalties.
(a) In partial consideration for the rights granted to Roche by Agouron
and JT, Roche hereby agrees to make the following non-refundable license issue
fee payments directly to Agouron and JT.
USD (MM)
On January 24, 1997
To Agouron $ 9.0
To JT 9.0
Within ten (10) days of the execution of this
Agreement
To Agouron 2.0
To JT 2.0
Within thirty (30) days of first regulatory approval
in a Major European
Country or upon marketing authorization from the European
Commission
To Agouron 11.0
To JT 11.0
Within thirty (30) days of first regulatory approval
in a country located in the Asian Licensed Territory
or upon marketing authorization in a country located
in the Asian Licensed Territory
To Agouron 1.0
To JT 1.0
TOTAL 46.0
(b) In partial consideration for the rights granted each of the
parties in this Agreement, the parties agree as follows:
(i) Roche shall pay Agouron and JT directly, a royalty based
on the Net Sales of Product by Roche, its Affiliates and sublicensees,
consolidated into CHF, in amounts which equal the greater of: (A) the
royalty amounts calculated according to Royalty Schedule 1 below
(Product only); or (B) the royalty amounts calculated according to
Royalty Schedule 2 below (Product and any formulations of INVIRASE
which Roche markets, with royalties being calculated separately for the
consolidated annual Net Sales of such Product and INVIRASE). Royalty
Schedule 2 shall not apply to Net Sales (including special license
sales) in a country located in the Licensed Territory until the
Registration of a Product in such country. A sum equal to one-half
(1/2) of the following royalties shall be paid by Roche directly to
each of Agouron and JT.
25
Royalty Schedule 1
Royalty Rate Consolidated Annual Net Sales Level
Per Consolidated of the Product in Licensed Territory
Annual Net Sales Level (other than the Asian Licensed Territory)
* <= *
* > CHF * <= CHF *
* > CHF *
plus
Royalty Rate Consolidated Annual Net Sales Level of
Per Consolidated the Product in the Asian Licensed
Annual Net Sales Level Territory
* <= USD *
* > USD * <= USD *
* > USD *
Royalty Schedule 2
Consolidated Annual Net Sales Level for
the Product and INVIRASE in the Licensed
Territory, other than the Asian Licensed
Royalty Rate Territory (With Royalties Being Calculated
Per Consolidated Separately for the Consolidated Annual
Annual Net Sales Level Net Sales of the Product and INVIRASE)
* <= CHF *
* > CHF * <= CHF *
* > CHF *
plus
Consolidated Annual Net Sales Level for the
Product and INVIRASE in the Asian Licensed
Royalty Rate Territory (With Royalties Being Calculated
Per Consolidated Separately for the Consolidated Annual
Annual Net Sales Level Net Sales of the Product and INVIRASE)
* <= USD *
* > USD * <= USD *
* > USD *
(ii) If either: (A) regulatory approval for the first Product
is not obtained in a Major European Country prior to * or (B)
marketing authorization for the first Product is not obtained from
the European Commission prior to *
the royalty rate for Royalty Schedule 2 for the Licensed
Territory (other than the Asian Territory) shall be adjusted as
follows.
26
Royalty Schedule 2
Consolidated Annual Net Sales Level for
the Product and INVIRASE in the Licensed
Territory (other than the Asian Licensed
Royalty Rate Territory) (With Royalties Being Calculated
Per Consolidated Separately for the Consolidated Annual Net
Annual Net Sales Level Sales of the Product and INVIRASE)
* <= CHF *
* > CHF * <= CHF *
* > CHF *
(iii) If regulatory approval for the first Product is not
obtained in Thailand prior to * and Roche has used reasonable diligence
in the development and Registration of a Product in the Field in
Thailand (including Roche's filing of a regulatory approval application
in Thailand during * ), the royalty rate for Royalty Schedule 2 for the
Asian Licensed Territory shall be adjusted as follows.
Royalty Schedule 2
Consolidated Annual Net Sales Level for the
Product and INVIRASE in the Asian Licensed
Royalty Rate Territory (With Royalties Being Calculated
Per Consolidated Separately for the Consolidated Annual
Annual Net Sales Level Net Sales of the Product and INVIRASE)
* <= USD *
* > USD * <= USD *
* > USD *
(iv) If either: (A) regulatory approval for the first
Product is not obtained in a Major European Country prior to *
or (B) marketing authorization for the first Product is not obtained
from the European Commission prior to
* Royalty Schedule 2 for the Licensed Territory (other than the Asian
Licensed Territory) shall not apply and Roche shall be obligated to pay
JT and Agouron directly, royalties according to Royalty Schedule 1 only
for the Licensed Territory (other than the Asian Licensed Territory).
(v) If regulatory approval for the first Product is not
obtained in Thailand prior to * and Roche has used reasonable diligence
in the development and Registration of a Product in the Field in
Thailand (including Roche's filing of a regulatory approval application
in Thailand * Royalty Schedule 2 for the Asian Licensed Territory shall
not apply and Roche shall be obligated to pay JT and Agouron directly,
royalties according to Royalty Schedule 1 only for the Asian Licensed
Territory.
(vi) If Roche files a regulatory approval application in
Thailand after *
then the milestone *
and *
dates specified in subparagraphs (iii) and (v) above shall be
deferred by the number
27
of days such regulatory application is filed after *
provided, however, that the above-referenced milestone dates
shall not be deferred for any day(s) where such delay is caused by
reasons beyond Roche's control.
(vii) If Roche markets any other HIV protease inhibitors in
the Licensed Territory during the term of this Agreement, sales for
such product(s) shall be included in the consolidated Net Sales
calculation according to Royalty Schedule 2.
(viii) The annual period Consolidated Annual Net Sales Level
for calculating royalties on Net Sales shall be the calendar year;
provided, however, that Net Sales occurring during the partial calendar
year period commencing with the Initial Commercial Sale of Product in
the Licensed Territory, shall be calculated on an annualized twelve
(12) month basis ending December 31.
(ix) If Agouron and JT are unable to deliver to Roche
significant amounts of Product ordered by Roche for commercial sale
(other than special license sales) in the Licensed Territory during the
period ending on the first anniversary of the marketing authorization
for the first Product from the European Commission (or regulatory
approval for the first Product in a Major European Country) and such
Product was ordered by Roche in a timely manner in accordance with
forecasting and ordering procedures agreed upon by the parties, then
the parties will discuss in good faith an adjustment in the
implementation of Schedule 2. *
Section 5.02 General Licensing Terms.
(a) No sales shall be deemed to have occurred as the result of sales
between and among the parties, their Affiliates and sublicensees; it being
understood that sales occur when made to non-Affiliated third party purchasers.
A sale of a Product shall be deemed to have been made upon the earliest of
invoicing or delivery of such Product for value to a non-Affiliated third party
purchaser. In the case of a sale or other disposal of a Product for value other
than in an
28
arm's-length transaction exclusively for money, such as barter or counter-trade,
sales shall be calculated using the fair market value of such Product (if higher
than the stated sales price) in the country of disposal.
(b) *
(c) *
(d) In calculating royalties with respect to a Combination Product, the
parties shall enter into good faith negotiations regarding the percentage of the
Net Sales of such Combination Product to be used in calculating royalties
payable with respect to such Combination Product on a country-by-country basis.
If the parties are unable to agree upon such percentage, royalties with respect
to a Combination Product in a country *
29
(e) Royalties due on the sale of a Product shall be owed from the date
of Initial Commercial Sale (or, if earlier, the first special license sale) by a
party, its Affiliates or sublicensees of such Product in a country of the
Licensed Territory, until the latest of: *
(f) The parties agree that the accounting and payment of royalties
shall comply with the following terms and conditions:
(i) As soon as possible, but no later than *
Roche shall provide to the authorized
representative of Agouron and JT with its good faith estimate of the amount of
Net Sales for such calendar month.
(ii) On or before the *
of each and every calendar year for as long as royalties
are due following the commencement of the marketing of Products, Roche shall:
(A) *
(iii) Roche's accounting of royalty *
shall be reviewed and signed by an appropriate financial employee of Roche,
and shall identify all relevant details regarding *
(iv) Any royalty payments due that are not paid on or
before the date such payments are due shall bear interest at *
30
(g) Roche shall maintain and cause its Affiliates and sublicensees to
maintain books of account and complete and accurate records pertaining to the
sale or other disposition of Products and of the royalty and other amounts
payable under this Agreement in sufficient detail to permit the authorized
representative of Agouron and JT to confirm the correctness of such items. *
(h) Roche shall be entitled to withhold from a royalty or other payment
due Agouron and/or JT, the amount, if any, of any withholding tax assessable to
the party due the payment, provided evidence of payment of any such tax is
promptly provided to the party for which the tax is withheld. If any taxes
(other than value-added taxes) are imposed on payments of royalties to Agouron
and/or JT and are required to be withheld therefrom, such taxes shall be for the
account of Agouron and/or JT, respectively, and the payments due to the party
for which tax is withheld shall be reduced accordingly. Roche shall advise
Agouron and/or JT and provide them with copies of the tax receipts for all taxes
deducted from the payment of royalties due them.
31
(i) The costs of defending or settling any claim or suit by any third
party for infringement of a patent of such third party by a party's practice of
the Patent Rights, Agouron/JT Technology, Roche Technology, and/or Development
Program Technology in discovering, developing, manufacturing or commercializing
the Compound, intermediates thereof and/or Products *
(j) Upon the expiration of the foregoing royalty obligations in a
country, which shall also be the expiration date of the licenses granted Roche
in such country pursuant to Sections 2.01(a) or 2.03, Roche *
intermediates thereof and Products in the
Field in such country on a non-exclusive basis; provided, however, that such
commercialization is subject to any other continuing obligations due Agouron and
JT, including license obligations under Section 2.01(j), if any.
(k) The parties agree in the future to use their reasonable efforts to
negotiate any additional licensing terms for the Compound, intermediates thereof
and/or Products which may be necessary to clarify the rights and obligations of
the parties.
Section 5.03 Foreign Currency.
(a) Development costs, Patent and Trademark costs, Adjusted Gross
Sales, Net Sales and any royalty amounts shall be stated in United States
dollars. Payments of development costs, Patent and Trademark costs and royalties
shall be made in United States dollars. Any required conversion of development
costs, Patent and Trademark costs, Adjusted Gross Sales, Net Sales and any
royalty amounts to United States dollars shall be done using the monthly average
rate of exchange for the calendar month in which such development costs, Patent
and Trademark costs, Adjusted Gross Sales, Net Sales and any royalty amounts
were incurred or first determined.
(b) The conversion from a foreign currency to United States
dollars shall be made by *
(c) *
32
(d) *
ARTICLE VI - TERM AND TERMINATION
Section 6.01 Termination for Breach. Either party may, at its option,
terminate this Agreement for cause in the event the other party shall commit a
material breach of this Agreement (including the failure of Roche to make the
payments described in Section 5.01(a) in a timely manner) and shall fail to cure
such breach during the one hundred twenty (120) day period (thirty (30) day
period in the case of any payment default) following receipt of a written notice
of such breach from the non-breaching party. After the end of the applicable
cure period, the party who has the right of termination may exercise its
termination option by giving the breaching party prior written notice of at
least fifteen (15) days of its election to terminate. Any termination of this
Agreement shall not release the breaching party from any obligations incurred
hereunder, and the non-breaching party shall be entitled to pursue an action for
damages arising as a result of such material breach. For purposes of this
Article VI, Agouron and JT shall be deemed to be a single party; an authorized
representative of Agouron and JT shall be entitled to take any actions which
Agouron and/or JT are entitled to take pursuant to the provisions of this
Article VI.
Section 6.02 Termination by Roche.
(a) Roche may elect to cancel the development and Registration of a
Product in the Field in a country located in the Licensed Territory upon one
hundred eighty (180) days written notice. If Roche elects to terminate its
participation in the development and Registration of a Product in the Field in a
country located in the Licensed Territory, it shall use its best efforts to
33
terminate its participation concurrently with the completion of its ongoing
clinical studies. In the event that Roche elects to discontinue the development
and Registration of a Product in the Field in a country located in the Licensed
Territory, subject to the provisions of the D&L Agreement, Agouron and JT, their
Affiliates and sublicensees shall be free, without any further action by
Agouron, JT or Roche, and without any further obligation to Roche and its
Affiliates, to continue to develop and/or commercialize Products in such country
on their own or with any third party, and to retain, use and disclose to any
such third party, information and materials which have been developed in the
development and Registration of the Product, provided that Agouron and JT shall
not disclose to such third party the confidential and proprietary information of
Roche (other than clinical, regulatory and manufacturing information and
materials specifically relating to such Product). In the event of the
discontinuation of Roche's development and Registration of a Product in the
Field in a country, the licenses granted to it by the provisions of Section 2.01
to use, offer for sale, sell and/or import in or into such country, such Product
in the Field under applicable Agouron/JT Patent Rights and Development Program
Patent Rights, and using applicable Agouron/JT Technology, Roche Technology and
Development Program Technology, shall be terminated, and Agouron and JT, their
Affiliates and sublicensees shall have no royalty or other obligations to Roche
and its Affiliates resulting from the manufacture, use, offer for sale, sale
and/or import in or into such country of the Compound, intermediates thereof
and/or Products by Agouron and JT, their Affiliates and sublicensees. Subject to
the provisions of the D&L Agreement: (i) Agouron and JT shall have the exclusive
right to Trademarks; (ii) Roche shall transfer ownership of any Dossiers for the
Product in such country to Agouron and JT; and (iii) Roche shall cooperate with
Agouron and JT to affect an orderly transition of Roche's development and
Registration responsibilities in such country to Agouron and JT. Roche shall be
responsible for the cost of its development activities in a country until the
effective date of such cancellation, including the expenses incurred in
terminating such activities and the costs of completing clinical studies which
were obligated to prior to its election to discontinue the development and
Registration of such Product in the Field in such country.
(b) Roche may elect to terminate its marketing rights for a Product on
a country-by-country basis upon one hundred eighty (180) days written notice. In
the event that Roche elects to terminate its marketing rights for a Product in a
country, subject to the provisions of the D&L Agreement: (i) the licenses
granted to Roche by the provisions of Section 2.01 to use, offer for sale, sell
and/or import in or into such country, such Product in the Field under
applicable Agouron/JT Patent Rights and Development Program Patent Rights, and
using applicable Agouron/JT Technology, Roche Technology and Development Program
Technology, shall be terminated, and Agouron and JT, their Affiliates and
sublicensees shall be free, without any further obligation to Roche and its
Affiliates, to market such Product in such country on its own or with any third
party; (ii) Agouron and JT, their Affiliates and sublicensees shall not have any
royalty or other obligations to Roche and its Affiliates resulting from the
manufacture, use, offer for sale, sale and/or import in or into such country of
the Compound, intermediates thereof and/or Products by Agouron and JT, their
Affiliates and sublicensees; (iii) Agouron and JT shall have the exclusive right
to Trademarks in such country; (iv) Roche shall transfer ownership to Agouron
and JT of any Dossiers for such Product in such country; and (v) Roche shall
cooperate
34
with Agouron and JT to affect an orderly transition of Roche's marketing
responsibilities in such country to Agouron and JT.
(c) If there is a material breach of this Agreement by Agouron and JT
but Roche nevertheless wishes to retain its rights granted by the terms of this
Agreement in the Compound and/or Products arising out of the Development
Program, then Roche shall not be entitled to terminate this Agreement for cause,
but shall only be entitled to pursue an action for damages arising as a result
of such material breach.
Section 6.03 Termination by Mutual Agreement. The parties may
at any time terminate this Agreement, in part or in its entirety, by mutual
written agreement.
Section 6.04 Termination Upon Bankruptcy. In the event that a party is
subject to any proceeding under the bankruptcy laws, or to the appointment of a
receiver, trustee or liquidator of its business or substantially all of its
assets, and such proceeding, if involuntary, is not dismissed or discharged
within one hundred fifty (150) days after such proceeding is instituted, or upon
the liquidation, dissolution, or winding up of its business, then this
Agreement, at the election of the other party, shall be terminated in its
entirety for cause upon a notice in writing of at least fifteen (15) days from
the party who is not bankrupt or insolvent.
Section 6.05 Disposition of Inventory. In the event of the cancellation
or termination of any license rights with respect to a Product, inventory of
such Product may be sold for up to six (6) months after date of cancellation or
termination, provided required payments, if any, are paid thereon.
Section 6.06 Effect of Termination. The termination of this Agreement
shall, to the extent not otherwise expressly provided herein, have no affect on
the rights and obligations of the parties under this Agreement with respect to:
(i) the parties' obligations of confidentiality, indemnification and
compensation for services performed; (ii) a party's liability for failure to
fulfill its obligations or undertakings under this Agreement; and (iii) the
rights or obligations of the parties otherwise expressly stated in the Agreement
to survive the termination of this Agreement. If this Agreement is terminated,
Agouron and JT's obligations under Section 2.02(b) shall terminate. Any other
provisions of this Agreement which by their nature are intended to survive
termination shall also survive. Upon any termination of this Agreement in its
entirety because of a breach of a party, neither party waives any rights to any
remedies it may have arising out of the termination. In the event of any breach
by a party with respect to obligations which continue after a termination in its
entirety of this Agreement, the non-breaching party shall have all remedies
available to it, as if the Agreement were still in effect on the date of such
breach.
35
ARTICLE VII - WARRANTIES AND COVENANTS; INDEMNITIES;
INSURANCE; DISPUTE RESOLUTION; GOVERNMENTAL APPROVALS; EXPORT CONTROLS
Section 7.01 Warranties and Covenants.
(a) Each party represents and warrants to the other parties that it has
the legal power, authority and right to enter into this Agreement and to perform
all of its respective obligations set forth herein, including the attachments
hereto.
(b) Agouron and JT each represents and warrants that, as of the date
this Agreement is executed, it was not aware of the existence of any patents
owned and Controlled by a third party covering the Compound which would
materially prevent the parties from commercializing the Compound in the Field in
the Licensed Territory. For purposes of this Section 7.01(b), the parties agree
that United States Patent No. 5,587,481 and United States Patent No. 4,439,613
and their foreign counterparts do not materially prevent the parties from
commercializing the Compound in the Field in the Licensed Territory.
(c) Each party covenants that it shall not commit any act or fail to
take any action which, in any significant way, would be in conflict with its
material obligations under this Agreement and the attachments hereto.
(d) Each party promises to comply in all material respects with the
terms of the licenses granted to it under this Agreement, and with all federal,
state, local and foreign laws, rules and regulations applicable to the
development, manufacture, distribution, import and export, and sale of
pharmaceutical products pursuant to this Agreement.
(e) EXCEPT AS OTHERWISE EXPRESSLY PROVIDED IN THIS AGREEMENT, EACH OF
THE PARTIES MAKES NO WARRANTIES, EXPRESSED OR IMPLIED, OF MERCHANTABILITY OR
FITNESS FOR A PARTICULAR PURPOSE OF ANY SUBJECT MATTER INCLUDED WITHIN THE
CLAIMS OF THE PATENT RIGHTS, INCLUDING THE COMPOUND. THE PARTIES UNDERSTAND AND
AGREE THAT DEVELOPMENT AND COMMERCIALIZATION OF THE COMPOUND AND/OR PRODUCTS
WILL INVOLVE APPROVAL BY REGULATORY AUTHORITIES, AND THAT NO PARTY IS
GUARANTEEING THE SAFETY OR EFFICACY OF THE COMPOUND AND/OR PRODUCTS, OR THAT THE
COMPOUND AND/OR PRODUCTS WILL RECEIVE THE REQUIRED APPROVALS.
Section 7.02 Indemnities; Insurance.
(a) Roche shall indemnify and hold harmless Agouron and JT, and their
Affiliates, employees, and agents (an "Agouron/JT Indemnified Party") from and
against any and all liabilities, losses, damages, costs, or expenses (including
reasonable investigative and attorneys' fees) which the Agouron/JT Indemnified
Party may incur, suffer or be required to pay resulting
36
from or arising in connection with any product liability or other claims, other
than claims for patent infringement, arising from the use by any person of any
Product, to the extent such product liability or other claim results from the
negligent, reckless or intentional misconduct of Roche, its Affiliates or
sublicensees, or their respective employees and agents, or on account of Roche's
failure to fulfill its obligations or undertakings under this Agreement;
provided, however, that in no event shall Roche be liable to an Agouron/JT
Indemnified Party for any indirect, incidental, special or consequential
damages, including loss of revenues or profits from sales of Products.
(b) Agouron and JT shall indemnify and hold harmless Roche and its
Affiliates, employees, and agents (a "Roche Indemnified Party") from and against
any and all liabilities, losses, damages, costs, or expenses (including
reasonable investigative and attorneys' fees) which the Roche Indemnified Party
may incur, suffer or be required to pay, resulting from or arising in connection
with any product liability or other claims, other than claims for patent
infringement, arising from the use by any person of any Product, to the extent
such product liability or other claim results from the negligent, reckless or
intentional misconduct of Agouron and/or JT, their Affiliates or sublicensees,
or their respective employees and agents, or on account of Agouron or JT's
failure to fulfill its obligations or undertakings under this Agreement;
provided, however, that in no event shall Agouron or JT be liable to a Roche
Indemnified Party for any indirect, incidental, special or consequential
damages, including loss of revenues or profits from sales of Products.
(c) To the extent that a product liability or other claim, other than a
claim for patent infringement, results from the negligent, reckless or
intentional misconduct of more than one party, their Affiliates, sublicensees,
or their respective employees and agents, the parties agree to share in an
equitable manner such liabilities, losses, damages, costs, or expenses in
proportion to the relative fault of each of the parties, their Affiliates,
sublicensees, or their respective employees and agents.
(d) Unless the parties agree otherwise, all other liabilities, losses,
damages, costs, or expenses (including reasonable investigative and attorneys'
fees) under this Section 7.02 relating to or involving a Product in a country,
except as provided by the terms of Sections 7.02(a), (b) and (c), shall be the
responsibility of the party marketing such Product in such country. The party
marketing a Product in a country shall indemnify the non-marketing party in such
country from and against any and all liabilities, losses, damages, costs, or
expenses (including reasonable investigative and attorneys' fees) which such
non-marketing party may incur, suffer or be required to pay resulting from or
arising in connection with any product liability or other claims, other than
claims for patent infringement, arising from the use by any person of such
Product in such country. Section 3.02 sets forth the parties' liability
obligations arising from claims for patent infringement.
(e) The aforesaid obligations of the indemnifying party shall be
subject to the indemnified party fulfilling the following obligations:
37
(i) The indemnified party shall fully cooperate with the
indemnifying party in the defense of any claims, actions, etc., which
defense shall be controlled by the indemnifying party.
(ii) The indemnified party shall not, except at its own cost,
voluntarily make any payment or incur any expense with respect to any
claim or suit without the prior written consent of the indemnifying
party, which consent such party shall not be required to give.
(iii) Promptly after receipt by the indemnified party of
notice of the commencement of any litigation or threat thereof which
may reasonably lead to a claim for indemnification, such party shall
notify the indemnifying party.
(f) The parties agree to maintain appropriate amounts of product
liability insurance coverage.
Section 7.03 Dispute Resolution. In the event of any controversy or
claim arising out of or relating to any provision of this Agreement or any term
or condition hereof, or the performance by a party of its obligations hereunder,
the parties shall try to settle their differences amicably between themselves.
If the representatives of the parties are unable to reach agreement on any such
issue, the issue shall be submitted for consideration, in the case of Roche, to
a designee of the Head of the Pharma Division of Roche and, in the case of
Agouron and JT, to one or more representatives jointly appointed by Agouron and
JT. If they are unable to agree, then the issue shall be resolved, in the case
of Roche, by the Head of the Pharma Division of Roche and, in the case of
Agouron and JT, by one or more representatives jointly appointed by Agouron and
JT. Any unresolved issues arising between the parties relating to, arising out
of, or in any way connected with this Agreement or any term or condition hereof,
or the performance by a party of its obligations hereunder, whether before or
after termination of this Agreement, except as otherwise provided in this
Agreement, shall be finally resolved by binding arbitration. Whenever a party
shall decide to institute arbitration proceedings, it shall give written notice
to that effect to the other party. The party giving such notice shall refrain
from instituting the arbitration proceedings for a period of sixty (60) days
following such notice. If Roche is the party initiating the arbitration, the
arbitration shall be held in San Diego, California, according to the rules of
the American Arbitration Association ("AAA"). If Agouron and JT, acting
collectively as a single party, is the party initiating the arbitration, the
arbitration shall be held in Newark, New Jersey, according to the rules of the
AAA. The arbitration shall be conducted by a single arbitrator mutually chosen
by the parties. If the parties can not agree upon a single arbitrator within
fifteen (15) days after the institution of the arbitration proceeding, then the
arbitration shall be conducted by a panel of three arbitrators appointed in
accordance with AAA rules; provided, however, that each party shall, within
thirty (30) days after the institution of the arbitration proceedings, appoint
one arbitrator with the third arbitrator being chosen by the other two
arbitrators. If only one party appoints an arbitrator, then such arbitrator
shall be entitled to act as the sole arbitrator to resolve the controversy. Any
arbitration hereunder shall be conducted in the English language, to the maximum
extent possible. All arbitrator(s) eligible to conduct the
38
arbitration must agree to render their opinion(s) within thirty (30) days of the
final arbitration hearing. The arbitrator(s) shall have the authority to grant
injunctive relief and specific performance and to allocate between the parties
the costs of arbitration in such equitable manner as he determines; provided,
however, that each party shall bear its own costs and attorneys' and witness'
fees. Notwithstanding the terms of this Section 7.03, a party shall also have
the right to obtain, prior to the arbitrator(s) rendering the arbitration
decision, provisional remedies, including injunctive relief or specific
performance, from a court having jurisdiction thereof. The arbitrator(s) shall,
upon the request of either party, issue a written opinion of the findings of
fact and conclusions of law and shall deliver a copy to each of the parties.
Decisions of the arbitrator(s) shall be final and binding on all of the parties.
Judgment on the award so rendered may be entered in any court having
jurisdiction thereof.
Section 7.04 Governmental Approvals. Roche, Agouron and JT shall obtain
any government approval(s) required to enable this Agreement to become
effective, or to enable any payment hereunder to be made, or any other
obligation hereunder to be observed or performed. Each party shall keep the
other informed of its progress in obtaining any such government approval and
shall cooperate with the other party in any such efforts.
Section 7.05 U.S. Export Controls. The parties agree to comply with the
United States laws and regulations governing exports and re-exports of the
Compound, intermediates thereof, Products, Development Program Technology,
Agouron/JT Technology, Roche Technology, or any other technology or software
developed or disclosed as a result of this Agreement. The parties acknowledge
that any performance under this Agreement is subject to any restrictions which
may be imposed by the United States laws and regulations governing exports and
re-exports. Each party agrees to provide the other parties with any reasonable
assistance, including written assurances which may be required by a competent
governmental authority and by applicable laws and regulations as a precondition
for any disclosure of technology or software by the other party under the terms
of this Agreement. The obligations of this Section 7.05 shall survive
termination or expiration of this Agreement.
ARTICLE VIII - DISCLOSURE OF AGREEMENT
Section 8.01 Disclosure of Agreement. Except as agreed to by the
parties, neither Agouron, JT nor Roche shall release any information to any
third party with respect to any of the terms of this Agreement without the prior
written consent of the other parties, which consent shall not unreasonably be
withheld. This prohibition includes, but is not limited to, press releases,
educational and scientific conferences, promotional materials and discussions
with the media. If a party determines that it is required by law to release
information to any third party regarding the terms of this Agreement, it shall
notify the other parties of this fact prior to releasing the information. The
notice to the other parties shall include the text of the information proposed
for release. The other parties shall have the right to confer with the notifying
party regarding the necessity for the disclosure and the text of the information
proposed for release. Notwithstanding the preceding, Roche, Agouron and JT shall
each have the right to disclose the terms of this Agreement to persons it
proposes to enter into business relationships with, if such
39
persons are subject to confidentiality and use obligations equivalent to those
applicable to the disclosing party hereunder.
ARTICLE IX - GENERAL PROVISIONS
Section 9.01 No Implied Licenses. Only the licenses granted pursuant to
the express terms of this Agreement shall be of any legal force and effect. No
license rights shall be created by implication or estoppel.
Section 9.02 No Waiver. Any failure by a party to enforce any right
which it may have hereunder in any instance shall not be deemed to waive any
right which it or the other parties may have in any other instance with respect
to any provision of this Agreement, including the provision which such party has
failed to enforce.
Section 9.03 Severability; Government Acts. In the event that any
provision of this Agreement is judicially, or by a competent authority,
determined to be unenforceable, in part or in whole, with regard to any or all
of the countries in the Territory, the remaining provisions or portions of this
Agreement shall be valid and binding to the fullest extent possible, and the
parties shall endeavor to negotiate additional terms, as feasible, in a timely
manner so as to fully effectuate the original intent of the parties, to the
extent possible, in the applicable countries. In the event that any act,
regulation, directive, or law of a country, including its departments, agencies
or courts should make impossible or prohibit, restrain, modify or limit any
material act or obligation of a party under this Agreement and, if any party to
this Agreement is materially adversely affected thereby, the parties shall
attempt in good faith to negotiate a lawful and enforceable modification to this
Agreement which substantially eliminates the material adverse effect; provided,
that, failing any agreement in that regard, the party who is materially
adversely affected shall have the right, at its option, to suspend or terminate
this Agreement as to such country.
Section 9.04 Ambiguities. Ambiguities, if any, in this Agreement shall
not be construed against any party, irrespective of which party may be deemed to
have authored the ambiguous provision.
Section 9.05 Notification of Authorities. After execution of this
Agreement, to the extent required by law, Agouron, after consultation with
Roche, shall notify the appropriate United States authorities about the terms of
this Agreement; JT, after consultation with Roche, shall notify the appropriate
Japanese authorities about the terms of this Agreement; and Roche, after
consultation with the authorized representative of Agouron and JT, shall notify
the appropriate European and other authorities about the terms of this
Agreement. The parties shall keep each other fully advised of the status and
progress of the notification procedures.
Section 9.06 No Agency. Agouron, JT and Roche shall have the status of
independent contractors under this Agreement and, except as otherwise explicitly
provided in this Agreement,
40
nothing in this Agreement shall be construed as an authorization of a party to
act as an agent of another party.
Section 9.07 Captions; Number; Official Language. The captions of the
Articles and Sections of this Agreement are for general information and
reference only, and this Agreement shall not be construed by reference to such
captions. Where applicable in this Agreement, the singular includes the plural
and vice versa. To the extent appropriate, the meaning of terms whose first
letters are capitalized, but which are variations of terms that are defined
elsewhere in this Agreement, shall each have the same meaning as the defined
term. English shall be the official language of this Agreement and any license
agreement provided for hereunder, and all communications between the parties
hereto shall be conducted in that language.
Section 9.08 Force Majeure. A party shall not be responsible to the
other parties for any failure, delay or interruption in the performance of any
of its obligations under this Agreement if such failure, delay or interruption
is caused by any act of God, earthquake, fire, casualty, flood, war, epidemic,
riot, insurrection, or any act, exercise, assertion or requirement of a
governmental authority, or other cause beyond the reasonable control of the
party affected if the party affected shall have used its best efforts to avoid
such occurrence. If a party believes that the performance of any of its
obligations under this Agreement shall be delayed or interrupted as a result of
any of the reasons stated in this Section 9.08, and provided such party is able
to do so, such party shall promptly notify the other parties of such delay or
interruption and the cause therefor, and shall provide such other parties with
its estimate of when the performance of its obligations shall recommence. When
the party affected is able to recommence the performance of obligations delayed
or interrupted as a result of any of the reasons stated in this Section 9.08, it
shall so notify the other parties and, except as otherwise provided in this
Agreement, it shall promptly resume the performance of such obligations.
Section 9.09 Amendment. This Agreement, including the Attachments and
Schedules, constitutes the full agreement of the parties with respect to the
subject matter of this Agreement, and incorporates any prior discussions between
them with respect to such subject matter; provided, however, that the
Confidential Disclosure Agreements ("CDAs") between the parties dated January 7,
1997 and April 3, 1997 shall be deemed by the parties to supplement the
confidentiality provisions of this Agreement. In the event of any inconsistency
between this Agreement and the LOI, including Exhibit A thereto, and/or the
CDAs, the terms of this Agreement shall govern. This Agreement, including the
attachments hereto, shall not be amended, supplemented or otherwise modified,
except by an instrument in writing signed by duly authorized officers of the
parties. Except as otherwise explicitly provided in this Agreement, nothing in
this Agreement shall be deemed to amend the rights and obligations of Agouron
and JT under the D&L Agreement, or otherwise amend the provisions of the D&L
Agreement.
Section 9.10 Applicable Law. This Agreement shall be construed and the
rights of the parties shall be determined in accordance with the laws of the
United States and the State of California, without regard to its conflict of law
provisions.
41
Section 9.11 Notices. Any notice required or permitted to be given
under this Agreement shall be in writing and shall be given in person, delivered
by recognized overnight delivery service, sent by mail (certified or registered
or air mail for addresses outside of the continental U.S.), or by telefax (or
other similar means of electronic communication), whose receipt is confirmed by
confirming telefax, and addressed, in the case of Agouron, to the Vice
President, Commercial Affairs (with a copy to the Legal Department), in the case
of JT, to the Vice President, Pharmaceutical Division (with a copy to the
International Legal Division) and, in the case of Roche, to the Head of
Strategic Marketing and Business Development of Pharma Division (with a copy to
the Legal Department), at the addresses shown at the beginning of this
Agreement, or such other person and/or address as may have been furnished in
writing to the notifying party in accordance with the provisions of this Section
9.11. Except as otherwise provided herein, any notice shall be deemed delivered
upon the earlier of: (i) actual receipt; (ii) two (2) business days after
delivery to such recognized overnight delivery service; (iii) five (5) business
days after deposit in the mail; or (iv) the date of receipt of the confirming
telefax.
Section 9.12 Assignment. This Agreement shall be assignable by Agouron
and/or JT, but shall not be assignable by Roche, except to an Affiliate, without
the prior written consent of both Agouron and JT, which consent may be withheld
at the sole discretion of Agouron or JT. Any such assignment without the prior
written consent of both Agouron and JT shall be void. If this Agreement is
assigned by Roche to an Affiliate, Roche shall still be responsible for all of
its obligations specified in this Agreement. Notwithstanding the preceding, in
the event of: (i) a sale or transfer of all or substantially all of Roche's
assets; or (ii) the merger or consolidation of Roche with another company, this
Agreement shall be assignable to the transferee or successor company.
Section 9.13 Succession. This Agreement shall be binding upon all
successors in interest, assigns, trustees and other legal representatives of
the parties.
42
IN WITNESS WHEREOF, the parties hereto have executed this Agreement, in
triplicate originals, by their respective officers thereunto duly authorized, as
of the Effective Date.
AGOURON PHARMACEUTICALS, INC. JAPAN TOBACCO INC.
By: /s/ ▇▇▇▇ ▇▇▇▇▇▇▇▇ By: /s/ Masakazu Kakei
Name: ▇▇▇▇ ▇▇▇▇▇▇▇▇ Name: Masakazu Kakei
Title: Corporate V.P. & Title: Executive Director,
General Counsel Pharmaceuticals
By: /s/ R. ▇▇▇▇ ▇▇▇▇▇▇ By: /s/ Y. Inubushi
Name: R. ▇▇▇▇ ▇▇▇▇▇▇ Name: Y. Inubushi
Title: Senior V.P., Head of Title: Vice President, Pharm. Division
Commercial Affairs
▇. ▇▇▇▇▇▇▇▇-▇▇ ▇▇▇▇▇ LTD
By: /s/ ▇. ▇▇▇▇▇▇▇
Name: ▇. ▇▇▇▇▇▇▇
Title: Director
By: /s/ ▇. ▇▇▇▇▇▇
Name: ▇. ▇▇▇▇▇▇
Title: Authorized Signatory
43
SCHEDULE 1
AGOURON/JT PATENT RIGHTS
"Agouron/JT Patent Rights" collectively means:
1. *
(a) *
(b) *
2. *
(a) *
3. *
4. *
5. *
6. *
S1-1
SCHEDULE 2
ASIAN LICENSED TERRITORY
"Asian Licensed Territory" means the following countries of Asia:
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
Licenses in the above-listed countries shall be subject to compliance by Roche
with the United States laws and regulations governing exports and re-exports of
Product and any technology developed or disclosed as a result of this Agreement.
S2-1
SCHEDULE 3
NELFINAVIR MESYLATE CLINICAL STUDIES
Results to be Contained in the MAA
---------------- ---------------------------------------------------------------
Protocol Title
---------------- ---------------------------------------------------------------
* *
---------------- ---------------------------------------------------------------
* *
---------------- ---------------------------------------------------------------
* *
---------------- ---------------------------------------------------------------
* *
---------------- ---------------------------------------------------------------
* *
---------------- ---------------------------------------------------------------
* *
---------------- ---------------------------------------------------------------
* *
---------------- ---------------------------------------------------------------
* *
---------------- ---------------------------------------------------------------
* *
---------------- ---------------------------------------------------------------
* *
---------------- ---------------------------------------------------------------
* *
---------------- ---------------------------------------------------------------
* *
---------------- ---------------------------------------------------------------
* *
---------------- ---------------------------------------------------------------
* *
---------------- ---------------------------------------------------------------
* *
---------------- ---------------------------------------------------------------
* *
---------------- ---------------------------------------------------------------
* *
---------------- ---------------------------------------------------------------
S3-1
SCHEDULE 3
NELFINAVIR MESYLATE CLINICAL STUDIES (Continued)
Interim Results to be Contained in the MAA
---------------- ---------------------------------------------------------------
Protocol Title
---------------- ---------------------------------------------------------------
* *
---------------- ---------------------------------------------------------------
* *
---------------- ---------------------------------------------------------------
* *
---------------- ---------------------------------------------------------------
* *
---------------- ---------------------------------------------------------------
* *
---------------- ---------------------------------------------------------------
* *
---------------- ---------------------------------------------------------------
S3-2
SCHEDULE 3
NELFINAVIR MESYLATE CLINICAL STUDIES (Continued)
Results to be Provided Later
---------------- ---------------------------------------------------------------
Protocol Title
---------------- ---------------------------------------------------------------
* *
---------------- ---------------------------------------------------------------
* *
---------------- ---------------------------------------------------------------
* *
---------------- ---------------------------------------------------------------
* *
---------------- ---------------------------------------------------------------
* *
---------------- ---------------------------------------------------------------
* *
---------------- ---------------------------------------------------------------
* *
---------------- ---------------------------------------------------------------
* *
---------------- ---------------------------------------------------------------
* *
---------------- ---------------------------------------------------------------
S3-3
ATTACHMENT 1
TRADEMARK LICENSE AGREEMENT
This Trademark License, effective as of January 17, 1997, is between Agouron
Pharmaceuticals, Inc., a corporation duly organized and existing under the laws
of the state of California, having a principal place of business at ▇▇▇▇▇ ▇▇▇▇▇
▇▇▇▇▇▇ ▇▇▇▇▇ ▇▇▇▇, ▇▇ ▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇ ▇▇▇▇▇▇ of America (hereinafter
referred to as "Agouron"), Japan Tobacco Inc., a corporation duly organized and
existing under the laws of Japan, having a principal place of business at JT
▇▇▇▇▇▇▇▇, ▇-▇, ▇▇▇▇▇▇▇▇▇ ▇-▇▇▇▇▇, ▇▇▇▇▇▇-▇▇, ▇▇▇▇▇, ▇▇▇▇▇ (hereinafter referred
to as "JT") and ▇. ▇▇▇▇▇▇▇▇-▇▇ ▇▇▇▇▇ Ltd, a corporation duly organized and
existing under the laws of Switzerland, having a principal place of business at
▇▇-▇▇▇▇-▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇▇ (hereinafter referred to as "Roche"). Agouron, JT and
Roche are each sometimes hereinafter each referred to as a party (collectively
"parties") to this Trademark License.
(Terms containing an initial capitalized letter, except as explicitly otherwise
indicated, shall have the meanings stated in the VIRACEPT License Agreement, as
defined below.)
BACKGROUND
On December 1, 1994, Agouron and JT entered into a Development and License
Agreement under which they have collaborated in the development and
commercialization of the chemical compound known as "nelfinavir mesylate"
[3S-(3R*,4aR*, 8aR*, 2'S*,
3'S*)]-2-[2'-hydroxy-3'-phenylthiomethyl-4'-aza-5'-oxo-5'-
(2"-methyl-3"-hydroxyphenyl)pentyl]-decahydroisoquinoline-3-N-t-butyl
carboxamide methanesulfonic acid salt)
(sometimes referred to herein as "VIRACEPT") to treat and prevent Human
Immunodeficiency Virus ("HIV") infections.
On January 17, 1997, Agouron, JT and Roche entered into a VIRACEPT License
Agreement. The VIRACEPT License Agreement, as now or as subsequently amended, is
hereinafter referred to as the "VIRACEPT License Agreement."
Agouron and JT have granted a license to Roche to sell VIRACEPT products to
treat and prevent HIV infections in certain countries of the world pursuant to
the terms of a Letter of Intent entered into by the parties on January 17, 1997
and the VIRACEPT License Agreement.
The VIRACEPT License Agreement provides that a form trademark license shall be
agreed upon by the parties and attached to the VIRACEPT License Agreement as
Attachment 1. The VIRACEPT License Agreement also contains the following
provisions concerning ownership and utilization of Trademarks:
A1-1
Section 1.26 "Trademark(s)" means any trademark selected and
owned by a party and registered (or applied for) by such party, its
Affiliate(s) and sublicensee(s) in the Territory for use in connection
with the marketing of Products. The definition of Trademark(s) shall
not refer to trade names used by a party to designate the name of such
party.
Section 2.01 License Grants. . . .
* * *
(j) *
Section 3.03 Trademarks. A party, its Affiliates and
sublicensees, if any, shall be free to use and to register in its own
name in any trademark office in the Territory any Trademark for use
with Products for which it holds license rights to make, use and/or
sell hereunder as it desires and in its sole discretion. Said party
shall own all right, title and interest in and to the Trademark in its
own name or that of its designated Affiliate or sublicensee, if any,
during and after the term of this Agreement. Notwithstanding the
preceding, *
Agouron and JT agree to share equally all
preparation, filing, prosecution and maintenance expenses in the
Licensed
▇▇-▇
▇▇▇▇▇▇▇▇▇ for the VIRACEPT Trademark which are payable to third
parties (excluding any travel expenses of the parties, which
shall be borne by the party incurring such expenses); each party shall
pay its share of such expenses within thirty (30) days from the date of
its receipt of a proper invoice for such expenses. The parties shall
not use a Trademark used in marketing of Products in the Licensed
Territory for marketing other commercial products in the Licensed
Territory. *
Each of the
parties shall annually prepare a list which reflects, to the best of
its knowledge, the current status of any Trademark which its owns.
Details regarding the license provisions of the Trademark license
granted in Section 2.01(j) hereof, including quality and specifications
of the Product, shall be agreed upon by the parties and later attached
hereto in Attachment 1 to this Agreement.
Section 4.03 Marketing. . . .
* * *
(d) It is the intent of the parties that the
VIRACEPT Trademark be identified and developed for use in connection
with the marketing of Products in the Field wherever possible
throughout the Territory. Unless otherwise agreed and as permitted by
law, Roche agrees to market Products in the Field under the VIRACEPT
brand name in all countries in the Licensed Territory. The parties also
acknowledge their intention to use, if appropriate, the same Trade
Dress in connection with the marketing of Products in the Field
wherever possible.
One or more of the parties is the owner(s) of the VIRACEPT Trademark, in certain
countries of the Territory.
The parties intend to use the VIRACEPT Trademark, including its associated
non-English translations (hereinafter collectively referred to as the "VIRACEPT
Trademark"), only in connection with the marketing of nelfinavir mesylate for
the treatment and prevention of HIV infections.
NOW THEREFORE, in accordance with the provisions of the VIRACEPT License
Agreement, for good and valuable consideration, the parties agree as follows:
A1-3
TRADEMARK LICENSE
1. Under the provisions of the VIRACEPT License Agreement, as more
specifically set forth above, each party granted to the other party,
its Affiliates and sublicensees a non-exclusive right to use the
granting party's Trademark(s) in the Territory in the marketing of
VIRACEPT products.
2. Products marketed using the VIRACEPT Trademark shall be
manufactured strictly in accordance with applicable governmental
statutes, regulations or directives.
3. The licensed user of the VIRACEPT Trademark shall comply with all
applicable governmental statutes, regulations or directives.
4. The licensed user of the VIRACEPT Trademark shall not use the VIRACEPT
Trademark in a manner which is deceptive, or which would bring the
VIRACEPT Trademark, the Product or the other parties, into disrepute.
Each party shall use the VIRACEPT Trademark, including its associated
non-English translations, only in connection with the marketing of
Products for the treatment and prevention of HIV infections. *
5. Pursuant to the terms of the VIRACEPT License Agreement, Agouron, JT
and Roche shall share obligations and responsibilities related
to Trademark(s). Provided a party fulfills its obligations
and responsibilities related to Trademark(s), and subject to the terms
of the VIRACEPT License Agreement, *
6. Each party shall, upon learning thereof, promptly notify the other
party in writing of any infringement by a third party of the parties'
rights in the VIRACEPT Trademark, or of any claim or suit by a third
party that the use of the VIRACEPT Trademark infringes or otherwise
violates the rights of a third party. The parties shall cooperate in
taking commercially reasonable legal actions to protect the parties'
rights in the VIRACEPT Trademark and/or to contest a claim by a third
party that the use of the VIRACEPT Trademark infringes or otherwise
violates any rights of a third party. *
7. Only the licenses granted pursuant to the express terms of this
Trademark License and the VIRACEPT License Agreement shall be of any
legal force and effect. No license rights shall be created by
implication or estoppel.
A1-4
8. This Trademark License shall terminate in accordance with the
provisions of the VIRACEPT License Agreement.
9. Any failure by a party to enforce any right which it may have hereunder
in any instance shall not be deemed to waive any right which it or the
other parties may have in any other instance with respect to any
provisions of this Trademark License, including the provision which
such party has failed to enforce.
10. In the event that any provision of this Trademark License is judicially
determined to be unenforceable, in whole or in part, the remaining
provisions or portions thereof shall be valid and binding to the
fullest extent possible, and the parties shall endeavor to negotiate
additional terms, as feasible, in a timely manner so as to fully
effectuate the original intent of the parties, to the extent possible.
Ambiguities, if any, in this Trademark License shall not be construed
against any party, irrespective of which party may be deemed to have
authored the ambiguous provision.
11. This Trademark License and the VIRACEPT License Agreement constitute
the full agreement of the parties with respect to the subject matter of
this Trademark License, and incorporate any prior discussions between
them with respect to such subject matter. This Trademark License shall
not be amended, supplemented or otherwise modified, except by an
instrument in writing signed by a duly authorized officer of each
party.
12. If there is a conflict between the terms of this Trademark License and
the VIRACEPT License Agreement, the terms of the VIRACEPT License
Agreement shall control.
13. This Trademark License shall be construed, and the rights of the
parties shall be determined, in accordance with the laws of the state
of California and the United States, without regard to conflict of law
provisions.
14. Any notice required or permitted to be given under this Trademark
License shall be in writing and shall be given in person, delivered by
recognized express delivery service, sent by mail (certified or
registered, or air mail for addresses outside of the continental U.S.),
or by telefax (or other similar means of electronic communication)
whose receipt is confirmed by confirming telefax, and addressed, in the
case of Agouron, to the Vice President, Commercial Affairs (with a copy
to the Legal Department), in the case of JT, to the Vice President,
Pharmaceutical Division (with a copy to the International Legal
Division) and, in the case of Roche, to the Head of the Pharma Division
(with a copy to the Legal Department) at the respective addresses shown
at the beginning of the VIRACEPT License Agreement, or such other
person and/or address as may have been furnished in writing to the
notifying party in accordance with the provisions of this paragraph.
Except as otherwise provided herein, any notice shall be deemed
delivered upon the earlier of: (i) actual receipt; (ii) two (2)
business days after delivery to a
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recognized express delivery service; (iii) five (5) business days
after deposit in the mail; or (iv) the date of receipt of the
confirming telefax.
15. This Trademark License shall be binding upon all successors in
interest, assigns, trustees and other legal representatives of the
parties.
IN WITNESS WHEREOF, the parties hereto have executed this Trademark License, in
triplicate originals, by their respective officers thereunto duly authorized as
of the day and year hereinabove written.
AGOURON PHARMACEUTICALS, INC. JAPAN TOBACCO INC.
By: /s/ R. ▇▇▇▇ ▇▇▇▇▇▇ By: /s/ Masakazu Kakei
Name: R. ▇▇▇▇ ▇▇▇▇▇▇, ▇▇. V.P. Name: Masakazu Kakei
Title:Head of Commercial Affairs Title:Executive Director Pharmaceuticals
By: /s/ ▇▇▇▇ ▇▇▇▇▇▇▇▇ By: /s/ ▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇
Name: ▇▇▇▇ ▇▇▇▇▇▇▇▇ Name: ▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇
Title:VP and General Counsel Title: Pharm Div. JT, Vice President
▇. ▇▇▇▇▇▇▇▇-▇▇ ▇▇▇▇▇ LTD
By: /s/ ▇. ▇▇▇▇▇▇▇
Name: ▇. ▇▇▇▇▇▇▇
Title:Director
By: /s/ ▇▇▇▇▇▇▇ ▇▇▇▇▇▇
Name: ▇▇▇▇▇▇▇ ▇▇▇▇▇▇
Title:Authorized Signatory
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ATTACHMENT 2
PRODUCT MANUFACTURING SPECIFICATIONS
THE TERMS OF THE PRODUCT MANUFACTURING SPECIFICATIONS WILL BE
CONTAINED IN THE APPLICABLE REGISTRATION FILING (S) FOR THE PRODUCT, AS AMENDED
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