Exhibit 10.43
CERTAIN CONFIDENTIAL INFORMATION CONTAINED
IN THIS DOCUMENT, MARKED BY BRACKETS, IS
FILED WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24b-2 OF THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
COPROMOTION AGREEMENT
This Agreement made this 27th day of September, 1996 by and between Roche
Laboratories Inc., a New Jersey corporation having its principal place of
business at 000 Xxxxxxxxx Xxxxxx, Xxxxxx, Xxx Xxxxxx 00000 (hereinafter referred
to as "ROCHE") and Gilead Sciences Inc., a Delaware corporation having a
principal place of business at 000 Xxxxxxxx Xxxxx, Xxxxxx Xxxx, Xxxxxxxxxx 00000
(hereinafter referred to as "GILEAD").
WITNESSETH
WHEREAS, ROCHE is presently marketing the product Roferon-Registered
Trademark--A (Interferon alfa-2a, recombinant) for certain cancer indications
and is now developing this product for treating hepatitis C; and
WHEREAS, GILEAD has a professional sales force that calls on physicians and
other health care professionals in order to promote GILEAD products; and
WHEREAS, ROCHE desires to enhance its marketing of the Product (as
hereinafter defined) for treating hepatitis C in the Territory (as hereinafter
defined) by enlisting the support and participation of the GILEAD sales force.
NOW, THEREFORE, for and in consideration of the mutual covenants contained
herein, ROCHE and GILEAD hereby agree as follows:
ARTICLE 1-DEFINITIONS
1.01 In the terms defined herein, the singular shall include the plural and
vice versa.
1.02 The effective date of this Agreement shall be the date the Agreement is
fully executed.
1.03 The term "Approval Date" shall mean the date the U.S. Food and Drug
Administration has approved the Product for marketing in the Field as
specified in the notice transmitted pursuant to Paragraph 7.01.
1.04 The term "Call" shall mean a visit by a professional sales representative
to a physician licensed to prescribe, dispense or administer legend drugs,
which visit is for the purpose of making a Primary Presentation on the
Product and involving no more than two other product presentations. Such
physician shall be selected from a target audience defined by the
Committee (as hereinafter defined).
1.05 The term "Calendar Year" shall mean a one year period commencing on
January 1. For instance, the first Calendar Year shall mean the period
from January 1, 1997 to December 31, 1998. The second Calendar Year shall
mean the period from January 1, 1998 to December 31, 1999.
1.06 The term "Field" shall mean the treatment of hepatitis C.
1.07 "Net Sales" shall be calculated by taking the gross sales of Product
invoiced by ROCHE and sublicensees in Territory to third parties, less
deductions of returns (including withdrawals and recalls), rebates (price
reductions, including Medicaid and similar types of rebates e.g.
chargebacks), volume (quantity) discounts, discounts granted at the time
of invoicing, sales taxes and other taxes directly linked to and included
in the gross sales amount (hereinafter "Adjusted Gross Sales"). In
addition, from the Adjusted Gross Sales, there shall be a lump sum
deduction of [ ] for those sales related deductions which
are not accounted for on a product by product basis (for example, without
limitation, outward freights, transportation insurance, packaging
materials for dispatch of goods, custom duties, discounts granted later
than at the time of invoicing, cash discounts, and product liability
insurance).
[ ] CONFIDENTIAL TREATMENT REQUESTED
2
1.08 The term "Primary Presentation" shall mean a full Product presentation
during which key product attributes are verbally presented; provided,
however, that no more than one presentation in any Call shall be
considered a Primary Presentation, which shall be the presentation on
which the most time is spent during the Call.
1.09 The term "Product" shall mean Roferon-Registered Trademark--A (Interferon
alfa-2a, recombinant) for use in the Field.
1.10 The term "The Term of this Agreement" shall mean the period specified in
Paragraph 7.01.
1.11 The term "Territory" shall mean the United States and its territories,
possessions and commonwealths.
ARTICLE 2 - GRANTS AND OBLIGATIONS
2.01 ROCHE hereby grants to GILEAD during the Term of this Agreement and under
the conditions herein imposed the right to promote and detail jointly with
ROCHE the Product under the trademark "ROFERON-A " for use in the Field in
the Territory. ROCHE shall not enter into any other copromotion or
similar arrangement with a third party regarding the Product for use in
the Field in the Territory during the Term of this Agreement. This
provision shall not preclude ROCHE from using contract personnel to detail
the Product. During the term of this Agreement, GILEAD shall not enter
into any other copromotion or similar arrangement with a third party in
the Field and within the Territory nor shall GILEAD market any other
product in the Field and within the Territory.
2.02 Subject to the provisions of and during the Term of this Agreement, each
party shall use its best efforts consistent with accepted business
practices and legal requirements to deploy its sales force to promote and
detail the Product for use in the Field in the
3
Territory in such manner and with such expedition as the party itself
would have adopted in launching, promoting and detailing a major
pharmaceutical Product of its own invention. In this regard, GILEAD will
provide a qualified field sales staff for detailing and promoting the
Product resulting in at least the number of Calls required pursuant to
Paragraph 2.03.
2.03 During each calendar year, GILEAD shall make at least [ ] Calls and
ROCHE shall make at least [ ] Calls. At the end of the third quarter
of each Calendar Year, ROCHE and GILEAD shall discuss the number of calls
each party is required to make in the subsequent Calendar Year. In the
event that the number of Calls which either party is required to make
changes, then the parties will agree on an appropriate adjustment to the
compensation structure provided in this Agreement.
ARTICLE 3 - PAYMENTS
3.01 Within thirty (30) days of the effective date of this Agreement, ROCHE
shall pay GILEAD a one time, nonrefundable (except as described in this
Section 3.01) fee of [ ] as compensation for its sales efforts
during the remainder of calendar year 1996. In the event that ROCHE does
not receive approval to market the Product by June 30, 1997, then ROCHE or
GILEAD may elect to terminate this Agreement and in such case GILEAD shall
return the [ ] fee minus any direct expenses incurred with regard
to preparing for the launch of the Product.
3.02 ROCHE shall pay GILEAD a royalty on net sales from the first Calendar Year
through the third Calendar Year according to the following three tiers of
gross sales. Gross sales falling within each tier shall first be
converted to Net Sales, against which the appropriate royalty shall be
applied.
[ ] CONFIDENTIAL TREATMENT REQUESTED
4
ROYALTY AS
% OF NET SALES
Gross sales from [ ] of base gross [ ]
sales forecast
Gross sales from [ ] of base gross [ ]
sales forecast
Gross sales greater than [ ] of base gross [ ]
sales forecast
The parties have agreed to base gross sales forecasts for Product of
[ ] in the first Calendar Year and [ ] in the
second Calendar Year. A base gross sales forecast for the third Calendar
Year shall be calculated as described in the following sentences and
equation:
At the end of the third quarter of second Calendar year, the Committee
shall determine a gross base sales forecast for the third Calendar Year.
For purposes of this calculation, an estimate of annual gross sales for
the second Calendar Year will be projected based upon gross sales for the
first three quarters of that year. In summary, the 1999 base gross
forecast shall be calculated as the product of the following three
variables:
(Roferon-A percentage market share) [ ]
in interferon Hepatitis C treatments in 1998
X
(The Compounded Annual Growth
Rate for the total dollar market for
interferon Hepatitis C treatments
from the period beginning January 1, 1997
to December 31, 1998)
X
(Total dollar market for interferon
Hepatitis C treatments in 1998)
[ ] CONFIDENTIAL TREATMENT REQUESTED
5
By way of example, if in 1997 gross sales of Product are [ ]
then the royalty payable to GILEAD shall be calculated as follows:
- 1997 base gross sales forecast = [ ]
- [ ] of 1997 base gross sales forecast = [ ]
- Net sales are assumed to be [ ] of gross sales, having assumed that
gross sales are reduced by [ ] to calculate Adjusted Gross Sales and
are further reduced by [ ] as a lump sum for additional allowed
indirect expense deductions, pursuant to Paragraph 1.07.
Gross Sales Net Sales Royalty Rate Royalty Due
----------- --------- ------------ -----------
[
]
With regard to an example for the determination of the base gross sales
forecast for 1999, assuming:
- The total market in 1998 for all interferon Hepatitis C products in
the Territory is [ ]
- The compounded annual growth rate for the total market for interferon
Hepatitis C products in the Territory from January 1, 1997 to December
31, 1998 is [ ]
- The annual gross sales of Product in 1998 are [ ] and
therefore the percentage market share for the Product among all
interferon Hepatitis C products in the Territory is [ ].
then the base gross sales forecast for 1999 shall be the following:
[ ]
[ ] CONFIDENTIAL TREATMENT REQUESTED
6
3.03 ROCHE will have no liability with respect to payments due GILEAD under
Paragraph 3.02 which might have been earned on the Product by GILEAD but
were not earned, or for any damage of any nature incurred by GILEAD in
anticipation of Net Sales which might have been earned but were not
earned, if, for any reason, including the negligence (but not the willful
misconduct) of ROCHE: (a) ROCHE is unable to ship the Product in the
Territory, (b) the Product is withdrawn from the market in the Territory,
(c) sales of the Product in the Territory do not reach a level reasonably
expected by previous sales, or any level or (d) Force Majeure as set forth
in Article 8. In the event that any of the foregoing occur, excluding
(c), in such a way that the financial assumptions underlying this
Agreement are no longer valid, then the parties will renegotiate the terms
of this Agreement in good faith.
3.04 Within [ ] after the close of each [ ]
during the Term of this Agreement, ROCHE shall submit to GILEAD a
statement showing: (i) the amount of gross sales and Net Sales including,
an itemized calculation of Adjusted Gross Sales, (ii) the deductions
provided for in Paragraph 1.07 during such [ ] and on a cumulative
basis year-to-date, and (iii) the calculation of payments to GILEAD
pursuant to Paragraph 3.02. The calculations provided for herein shall be
subject to audit pursuant to Paragraph 4.15.
3.05 For the one year period commencing upon the expiration of this Agreement
("Residual Year"), ROCHE shall pay GILEAD [ ] of the
total amount paid to GILEAD for the previous calendar year pursuant to
paragraph 3.02. The payment for the Residual Year shall be made in equal
[ ] installments within [ ] after the end of
each [ ] of the Residual Year.
3.06 Under the provisions of this Agreement, all sums due to GILEAD for sales
of the Product for use in the Field within the Territory hereunder will be
payable by ROCHE in U.S. Dollars via wire transfer to GILEAD's account at
the following address:
[ ] CONFIDENTIAL TREATMENT REQUESTED
7
Xxxxx Fargo Bank
000 Xxxxxx Xxxxxx, 0xx Xxxxx
Xxx Xxxxxxxxx, XX 00000
Attn: Xxxx Xxxxxxxx
ABA # 121000 248
Dept. # 068
Acct. # 324-112069
Acct. Name: Gilead Sciences, Inc.
or any other place or bank account as GILEAD may designate to ROCHE in
writing. A copy of relevant report upon which said payment was based will
also be sent by ROCHE to GILEAD at the following address:
Gilead Sciences, Inc.
000 Xxxxxxxx Xxxxx
Xxxxxx Xxxx, XX 00000
Attn: Chief Financial Officer
(000) 000-0000
3.07 Notwithstanding anything in this Agreement to the contrary, in the event
that ROCHE's actual Net Sales in the Territory are reduced, due to
credits, refunds, voluntary or government mandated recalls for any reason
at any time within six (6) months after the completion of any Calendar
Year for which Net Sales have been accrued pursuant to the terms of this
Agreement, then the Net Sales for the Calendar Year in which such credits,
refunds, recalls, etc. occur shall be reduced accordingly and GILEAD shall
return to ROCHE within sixty (60) days of receipt of a notice from ROCHE
requesting such return, any dollar amounts which were paid to GILEAD in
respect of Net Sales during such Calendar Year which are in excess of the
dollar amounts which would have been paid to GILEAD if the Net Sales for
such period reflected the Net Sales actually obtained by ROCHE taking
into account such credits, recalls, refunds or other deductions.
3.08 Within sixty (60) days of the execution of this Agreement, ROCHE and
GILEAD shall agree to an appropriate methodology including the selection
of an independent third party source to determine total sales of the
Product in the Field within the Territory and market
8
share relative to all interferon products sold for the treatment of
Hepatitis C. The establishment of sales and market share data described
in this Paragraph shall be at the expense of ROCHE.
3.09 If the difference between the gross sales of Product and the Adjusted
Gross Sales of Product is more than [ ] of the gross sales
of Product for any given quarter as a result of Product rebates or other
pricing matters due to competition in the marketplace, then the parties
will renegotiate in good faith the terms of this Agreement.
ARTICLE 4 - COOPERATION, RIGHTS AND RESPONSIBILITIES
It is among the objectives of the parties to promote and detail the
Product for use in the Field within the Territory in the most effective
and efficient fashion. To achieve this and other objectives, the parties
agree as follows:
4.01 The parties shall each appoint an authorized representative
("Coordinator") with whom communications between the parties relating to
marketing and sales of the Product will be directed. Each party will
notify the other as to the name of the individual so appointed. Each party
may replace its Coordinator at any time, upon written notice to the other
party.
4.02 (a) The Coordinators shall establish a Committee directed by the Roche
Coordinator and consisting of an equal number of representatives of each
party which will meet at least quarterly, at mutually agreeable times and
locations, to discuss and coordinate the joint promotion and detailing of
the Product for use in the Field in the Territory and the strategies and
programs that should be developed to maximize Net Sales. Illustratively,
the Committee shall (i) coordinate the launch of the Product for use in
the Field in the Territory and (ii) guide all continuing joint promotion
and detailing efforts with respect to the Product for use in the Field in
the Territory. Although the parties intend to work cooperatively, ROCHE
will have authority and final responsibility for developing
[ ] CONFIDENTIAL TREATMENT REQUESTED
9
marketing strategies and tactics including but not limited to detailing
strategies with respect to the Product.
(b) The Committee shall develop and formulate marketing plans for
specified periods (collectively the "Marketing Plan") which shall set
forth marketing strategies and tactics relating to the Product. ROCHE,
however, shall have the final responsibility for, and control over, the
development and content of the Marketing Plan.
(c) Efforts will be made at the sales territory level to coordinate the
Calls by the ROCHE sales force with the Calls by the GILEAD sales force to
ensure the most effective coverage of the target audiences and to minimize
non-productive efforts.
(d) A party shall have the right to comment upon and make recommendations
to the other party regarding the other party's activities under this
Agreement, which recommendations the other party shall thoroughly evaluate
and consider.
(e) Each party shall bear its own costs associated with its participation
in the Committee and its activities performed under this Agreement.
4.03 (a) During the Term of and subject to any other provision of this
Agreement, each party will provide the other with all information relevant
to the detailing and promotion of the Product for use in the Field within
the Territory within a reasonable time after such information becomes
known to the party, provided such information is not received from an
independent third party under a secrecy obligation. Specifically, the
sales force of each party will receive the same information at the same
time with respect to the Product.
(b) During the Term of this Agreement, each party shall promptly notify
the other party of all information coming into its possession concerning
unexpected side effects, injury, toxicity or sensitivity reaction
including unexpected incidence and severity thereof associated with
commercial or clinical uses, studies, investigations or tests with the
10
Product (animal or human), throughout the world, whether or not determined
to be attributable to the Product ("Adverse Reaction Reports"). In the
case of Adverse Reaction Reports within the scope of 21 CFR
314.80(c)(iii), GILEAD shall transmit such Adverse Reaction Reports so
that they are received by ROCHE within three (3) business days after
receipt by GILEAD, or such other reporting period as may be required by
law. ROCHE shall transmit Adverse Reaction Reports to GILEAD on a
periodic basis, but no less often than once every three (3) months;
provided, however, that ROCHE shall promptly notify GILEAD of any Adverse
Reaction Report requiring the alteration of detailing activities by the
GILEAD sales force. All such communications shall be held in the
strictest confidence by GILEAD and shall be subject to the terms of
Paragraph 4.14.
4.04 GILEAD warrants and represents that it will maintain records of Calls made
by its sales force and that these records will accurately represent the
number of Calls made and the relative emphasis given to each Product
during a Call. For all Calendar Years covered by this Agreement, GILEAD
shall issue reports to ROCHE within [ ] after the end of
[ ] of such Calendar Year showing the number of Calls made to
each audience and the relative emphasis assigned to the Product in such
Calls. ROCHE shall be entitled to audit the source data and documents
used to compile such reports pursuant to the provisions of Paragraph 4.15
of this Agreement.
4.05 ROCHE retains and shall retain all proprietary rights and proprietary
interests in the Product until the point of sale and in all supporting
sales and promotional and educational material. GILEAD will not have nor
represent that it has any control or proprietary or property interests in
the Product. Nothing contained herein shall be deemed to grant GILEAD,
either expressly or implied by a license or other right or interest in any
patent, trademark, copyright or other similar property of ROCHE except as
may be necessary for GILEAD to promote and detail the Product as provided
for in this Agreement.
4.06 (a) During the Term of this Agreement, at ROCHE's cost, ROCHE shall create
and develop all sales and promotional materials relating to the Product
for distribution for use
[ ] CONFIDENTIAL TREATMENT REQUESTED
11
in the Field. ROCHE shall provide GILEAD with such materials, in amounts
which are reasonable under the terms of the Marketing Plan. Other than
with the advice and consent of ROCHE, GILEAD shall not create or develop
sales, promotional or other similar materials relating to the Product for
distribution to independent third parties.
All sales and promotion material for distributing the Product for use in
the Field which is prepared primarily through a printing technique (except
for memo pads and the like) shall be supplied by ROCHE, free of all
charge, to GILEAD.
All sales and promotional materials relating to the distribution of the
Product for use in the Field which are multi-dimensional in form,
including memo pads and the like, and materials which are prepared
primarily by techniques other than printing shall be supplied to GILEAD by
ROCHE in accordance with paragraph 4.07 of this Agreement.
(b) GILEAD shall not be required to distribute any sales and promotional
material prepared after the date of this Agreement which (i) does not
present GILEAD to the medical and paramedical communities and to the trade
as joining with ROCHE in the detailing and promotion of the Product, (ii)
does not mention the Product, or (iii) includes reference to another ROCHE
pharmaceutical in addition to the Product. At ROCHE's request, and at
GILEAD's sole option, GILEAD may distribute sales and promotion material
of the type identified in this subparagraph (b). Should GILEAD elect to so
distribute such material, it shall be supplied to GILEAD by ROCHE free of
all charge. In no event shall ROCHE be required to distribute any material
which contains a reference (i) to GILEAD (other than in connection with
the joint detailing and promotion of the Product in accordance with this
Agreement) or (ii) any GILEAD pharmaceutical.
4.07 To achieve the objectives of this Agreement, it may be necessary to
distribute multi-dimensional sales and promotional materials, including
memo pads and the like and/or materials which are prepared primarily by
techniques other than printing (all of these materials being hereinafter
identified as "Materials") to health care personnel and
12
the trade on an ongoing basis ("Program"). If in ROCHE's sole judgment it
determines that such a Program is best to achieve these objectives, ROCHE
shall provide GILEAD, free of charge, with all of GILEAD's reasonable
requirements for Materials. ROCHE shall cause the production of all
Materials and shall ship GILEAD's requirements of Materials to such
GILEAD's facilities as GILEAD may designate, F.O.B., the ROCHE
distribution site. Materials shall be allotted on a per capita basis to
the ROCHE sales force and the GILEAD sales force as modified by the
expected amount of time and effort to be used by each sales force in
detailing and promoting the Product for use in the Field. All Materials
delivered to GILEAD shall be packaged in the same form and be of the same
quality as those which ROCHE normally distributes to health care personnel
or to the trade in the Territory.
4.08 Each party shall contribute facilities, supplies, personnel (including
management and sales representatives) and other resources without charge
or expense to the other as each party, in its absolute discretion,
believes necessary for the proper performance of terms of this Agreement,
and each party shall bear its own costs incurred in the performance of any
obligations hereunder. Neither party shall have any responsibility for
the firing or compensation of the other party's employees or for any
employee benefits. No employee or representative of a party shall have
any authority to bind or obligate the other party to this Agreement for
any sum or in any manner whatsoever, or to create or impose any
contractual or other liability on the other party without said party's
authorized written approval. For all purposes, and notwithstanding any
other provision of this Agreement to the contrary, GILEAD's legal
relationship under this Agreement to ROCHE shall be that of independent
contractor.
4.09 ROCHE shall have the sole responsibility for the manufacture and
distribution of Product in the Territory. ROCHE shall also be
responsible for insuring that sufficient stock of the Product will be
available in its inventory to promptly fill orders in the Territory from
the trade except for Force Majeure as defined in Article 8.
13
4.10 (a) With respect to the Product, ROCHE and GILEAD shall both employ the
Trademark "Roferon-Registered Trademark--A" on all promotional literature
relating to the Product for use in the Territory such as detailing aids
and advertising directed to the Product. All such promotional literature
shall identify the Product as being promoted by ROCHE/GILEAD. At ROCHE's
discretion, all literature which sets forth the Product and sets forth
with at least equal emphasis to the Product, one or more other Products
distributed or sold by ROCHE need not set forth or identify the Product as
being promoted by ROCHE/GILEAD but can simply identify the Product as a
ROCHE Product without the name of GILEAD appearing on said literature.
(b) During the term of this Agreement after approval of the supplemental
new drug application (NDA) by the United States Food and Drug
Administration (FDA) directed to the Product and before launch of the
Product, ROCHE shall provide reasonable assistance to GILEAD, free of
charge, for training and orientation of the GILEAD sales force. ROCHE will
provide GILEAD, free of charge, with reasonable quantities of training
materials which have been created and developed by ROCHE relating to the
Product and its use in the Field. During the term of this Agreement,
GILEAD will not permit any of its sales personnel to promote the Product
unless such sales personnel have been qualified under criteria and/or
tests supplied by ROCHE, which either will be the same as those used to
qualify ROCHE sales personnel or will be approved by ROCHE. The costs of
training the GILEAD sales training personnel incurred by GILEAD shall be
borne by GILEAD.
(c) Neither party shall distribute or have distributed any such
information, except for promotional literature prepared by ROCHE under
subparagraph (a) of this paragraph, which bears the name of the other
without the prior written approval of the other, which approval shall not
be unreasonably withheld. The Product shall be represented solely as a
ROCHE Product. When packaged, the Product will bear the trademark and
label of ROCHE only. All promotional materials or other information
regarding the Product, if any, which is distributed other than to medical
or paramedical communities or trade, will
14
not be required to identify GILEAD's involvement in the detailing or
promotion of the Product, but may so identify said involvement if ROCHE in
its sole discretion deems it appropriate to do so.
(d) (i) ROCHE at its option may issue press releases or other public
announcements relating to the Product or the arrangement contemplated by
this Agreement (including a joint press release with GILEAD upon execution
of this Agreement), provided however, that ROCHE shall not issue a press
release or public announcement which relates to the arrangement
contemplated by this Agreement, except for references to GILEAD and the
relationship created by this Agreement in ROCHE's annual and quarterly
reports and other SEC documents, without the prior written approval of
GILEAD, which approval shall not be unreasonably withheld.
(ii) GILEAD at its option may issue press releases or other public
announcements relating to the Product or the arrangement contemplated by
this Agreement (including a joint press release with ROCHE upon execution
of this Agreement), provided however, that GILEAD shall not issue a press
release or public announcement which relates to the arrangement
contemplated by this Agreement, except for references to ROCHE and the
relationship created by this Agreement in GILEAD's annual and quarterly
reports and other SEC documents, without the prior written approval of
ROCHE, which approval shall not be unreasonably withheld.
4.11 (a) ROCHE shall have the sole right and responsibility, and shall bear all
costs related thereto, to take such actions with respect to the Product as
would normally be done in accord with accepted business practices and
legal requirements to obtain and maintain the authorization and/or ability
to market a major pharmaceutical Product in the Territory, including,
without limitation, the following:
15
(l) responding to Product and medical complaints relating to the
Product. GILEAD agrees that it shall refer any such complaints which
it receives to ROCHE as soon as reasonably practicable;
(2) handling all returns of the Product. If the Product is returned to
GILEAD, it shall be shipped to ROCHE's nearest facility, with any
reasonable or authorized shipping or other documented direct cost to
be paid by ROCHE. GILEAD shall incur no liability of any nature in
the handling of such returns. GILEAD, if requested, shall advise the
customer who made the return that the Product has been returned to
ROCHE;
(3) handling all recalls of the Product. At ROCHE's request and GILEAD's
option, GILEAD will assist ROCHE in receiving the recalled Product
and any direct documented costs incurred by GILEAD, with respect to
participating in such recall shall be reimbursed by ROCHE;
(4) communicating with any governmental agencies and satisfying their
requirements regarding the authorization and/or continued
authorization to market the Product in commercial quantities in the
Territory;
(5) reporting Adverse Reaction Reports to U.S. regulatory authorities as
required by applicable U.S. law or regulation;
(6) handling Product distribution, inventory and receivables.
(b) Each party shall respond to medical questions or inquiries relating to
the Product directed to such party. Within a reasonable time from the date
of this Agreement, but in no event later than the Approval Date, ROCHE
shall provide GILEAD with all reasonably necessary information which would
enable GILEAD to respond properly and promptly to any such questions or
inquiries. All such information shall be held in the
16
strictest confidence by GILEAD and shall be subject to the terms of
Section 4.13 hereof except with regard to providing the proper response to
medical questions or inquiries relating to Product. ROCHE shall use its
best efforts to keep such information current. GILEAD and ROCHE shall
coordinate responses to anticipated inquiries and questions.
4.l2 Notwithstanding the Marketing Plan or any other provision herein to the
contrary, ROCHE will have the sole right and responsibility for
establishing and modifying the terms and conditions with respect to the
sale of the Product, including the price at which the Product will be
sold, any discount attributable to payments on receivables, distribution
of the Product and the like.
4.13 If, for any reason, GILEAD should receive orders for the Product, GILEAD
shall use its best efforts to forward such orders to ROCHE as soon as
practicable.
4.14 Any information provided to GILEAD by ROCHE (or by anyone who was under a
non-disclosure obligation to ROCHE) under this Agreement, except that
information:
(a) which becomes public through no fault of GILEAD; or
(b) which was known by GILEAD prior to its disclosure to GILEAD by ROCHE;
or
(c) which is lawfully obtained by GILEAD from a third party which is
independent of ROCHE and said third party is in lawful possession of said
information; or
(d) which is required to be disclosed by applicable law or regulation; or
(e) which is intended for distribution to the trade:
shall be treated with the strictest confidence and GILEAD shall not use
any such information for any purposes other than that provided in this
Agreement.
17
GILEAD shall keep such information in a special file which shall be solely
under the direction and control of the GILEAD Coordinator. GILEAD shall
not distribute any such information except to its employees who have a
need to know such information. Any GILEAD employee who receives such
information shall be advised of the confidential nature thereof and the
prohibitions contained in this section. The Coordinator will use best
efforts to keep a record of those individuals who have received copies of
the information or any portions thereof, and all copies or any portions
thereof will be identified by GILEAD as confidential. Upon termination of
this Agreement, and upon the request of ROCHE, GILEAD shall return or
destroy all such information and copies thereof in its possession, except
that GILEAD may keep one copy of such information in GILEAD's Law
Department files solely for archival purposes. Such archival copy will be
deemed to be the property of ROCHE, and will not be copied or distributed
in any manner without the express prior written permission of ROCHE. The
prohibitions contained herein shall survive the termination of this
Agreement and last for a period of ten (10) years from the date of
termination of this Agreement.
4.15 Each party shall keep, and shall cause its Affiliates and sublicensees to
keep, complete and accurate records pertaining to the Calls (by GILEAD or
ROCHE) or sale or other disposition of Product and of the Royalty and
other amounts payable under this Agreement in sufficient detail to permit
the other party to confirm the accuracy of all Calls completed and
payments due hereunder. At either party's request, the other party will
cause its independent certified public accountants to prepare abstracts of
its relevant business records for review by the other party's independent
certified public accountants. If, based on a review of such abstracts, a
party reasonably believes that a full audit of said business records would
be necessary for the confirmation of the accuracy of all Calls and
payments due hereunder, that party's independent certified public
accountants shall have full access to review all work papers and
supporting documents pertinent to such abstracts, and shall have the right
to discuss such documentation with the other party's independent certified
public accountants. [
[ ] CONFIDENTIAL TREATMENT REQUESTED
18
] Such audit rights may be
exercised no more often than once a year, within three (3) years after the
payment period to which such records relate, upon notice to the party
being audited and during normal business hours. The party requesting such
audit will bear the full cost of such audit unless such audit discloses an
underpayment of more than five percent (5%) from the amount of Calls made
or royalties due. The terms of this Paragraph shall survive any
termination or expiration of this Agreement for a period of three (3)
years.
4.16 Each party will utilize its own sales force to promote and detail the
Product. During the Term of this Agreement, neither party will recruit or
employ any sales representative of the other party who has been involved
in promotion of the Product in the Territory. In addition, neither party
will recruit any sales representative of the other party without prior
consultation with the other party.
ARTICLE 5 - WARRANTIES AND INDEMNIFICATION
5.01 Each party warrants and represents to the other that it has the full right
and authority to enter into this Agreement, and that it is not aware of
any impediment that would inhibit its ability to perform its obligations
under this Agreement.
5.02 ROCHE warrants and represents that it has no knowledge of the existence of
any U.S. patent owned or controlled by anyone other than ROCHE which would
prevent ROCHE
[ ] CONFIDENTIAL TREATMENT REQUESTED
19
from making, using or selling the Product for use in the Field within the
Territory or would prevent GILEAD and ROCHE from jointly promoting or
detailing the Product for use in the Field within the Territory.
5.03 ROCHE will defend, indemnify and hold harmless GILEAD and its directors,
officers, employees and agents against all losses, expenses, claims and
liabilities, known and unknown, of any kind, including all costs and
expenses relating thereto arising at any time as a result of any assertion
relating to the manufacture, handling, use or distribution of Products by
ROCHE, or their sublicensees except to the extent that they result from
acts or omissions of acts of GILEAD, its directors, officers, employees or
agents.
5.04 GILEAD will defend, indemnify and hold harmless ROCHE and its directors,
officers, employees and agents against all losses, expenses, claims and
liabilities, known and unknown, of any kind, including all costs and
expenses relating thereto arising at any time as a result of any assertion
relating to the promotion of Products by GILEAD, except to the extent that
they result from acts or omissions of acts of ROCHE, its directors,
officers, employees or agents
5.05 Regarding the indemnity and hold harmless under Paragraph 5.03, GILEAD
shall give prompt written notice to ROCHE of the commencement of any
action, suit or proceeding for which indemnification may be sought, and
ROCHE shall assume the defense thereof; provided, however, that GILEAD
shall be entitled to participate in any such action, suit or proceeding
with counsel of its own choice, but at its own expense. If ROCHE fails to
assume the defense within a reasonable time, GILEAD may assume such
defense and the reasonable fees and expenses of its attorneys will be
covered by the indemnity provided for in Paragraph 5.03 above. No such
action, suit or proceeding shall be compromised or settled in any manner
which might adversely affect the interests of ROCHE without prior written
consent of ROCHE which consent shall not be unreasonably withheld. ROCHE
agrees to consult with GILEAD with respect to any proposed compromise or
settlement which would adversely affect the interests of GILEAD.
20
ARTICLE 6 - PATENTS AND TRADEMARK INFRINGEMENT
GILEAD shall advise ROCHE promptly upon its becoming aware of any
infringement by a third party of a patent or trademark owned by ROCHE and
respectively covering or identifying the Product in the Territory. If
warranted in the opinion of ROCHE, ROCHE shall promptly take such legal
action as is required to restrain such infringement. GILEAD shall
cooperate fully with and as requested by ROCHE, at ROCHE's expense, in
ROCHE's attempt to restrain such infringement. GILEAD may be represented
by counsel of its own selection at its own expense in any suit or
proceeding brought to restrain such infringement but ROCHE shall have the
right to control the suit or proceeding.
ARTICLE 7 - TERM AND TERMINATION
7.01 The term of this Agreement shall commence on the effective date of this
Agreement and continue, unless terminated sooner in accordance with the
subsequent provisions of this Article, until December 31, 1999.
Upon termination of this Agreement for any reason or purpose, all rights
to The Product including but not limited to regulatory submissions and
trademarks become or remain the property of ROCHE.
ROCHE shall notify GILEAD in writing of the Approval Date within ten (10)
days thereof.
Paragraphs 3.05, 3.06, 4.05, 4.10(d), 4.11(a), 4.14, 4.15, 5.03 and 5.04
shall survive expiration or termination of this Agreement for any reason.
21
7.02 Either party may terminate this Agreement for Good Cause (as defined in
Paragraph 7.03 below), effective at any time after providing sixty (60)
days written notice and, if applicable, an opportunity to cure during such
sixty (60) day period (if such cure is effected, such notice with respect
to such Good Cause shall be null and void). If the Agreement is so
terminated by either party for Good Cause, ROCHE shall pay to GILEAD all
dollar amounts due to it under Sections 3.02 and 3.05 through the
effective date of such termination.
7.03 "Good Cause" shall include the failure of the other party to comply with
any of its material obligations contained in this Agreement (including the
failure to detail the Product).
7.04 Termination of this Agreement for Good Cause, shall be without prejudice
to (a) any remedies which any party may then or thereafter have hereunder
or at law; and (b) GILEAD's right to receive any payment accrued under the
Agreement prior to the termination date but which became payable
thereafter; and (c) either party's right to obtain performance of any
obligations provided for in this Agreement which survive termination by
their terms or by a fair interpretation of this Agreement.
7.05 Either party may terminate this Agreement for any reason, effective as
of January 1, 1999, by delivering written notice to the other party on or
prior to October 31, 1998.
ARTICLE 8 - FORCE MAJEURE
If either party shall be delayed, interrupted in or prevented from the
performance of any obligation hereunder by reason of an act of God, fire,
flood, earthquake, war (declared or undeclared), public disaster, strike
or labor differences, governmental enactment, rule or regulation, or any
other cause beyond such party's control, such party shall not be liable to
the other therefor; and the time for performance of such obligation shall
be extended
22
for a period equal to the duration of the contingency which occasioned the
delay, interruption or prevention.
Within 15 days of the beginning of the Force Majeure, the party invoking
its Force Majeure rights must, by registered letter notify the other party
of this fact. The termination of the Force Majeure must also be notified
to the other party by registered letter within 15 days of such
termination. If the Force Majeure renders either of the required
notifications impossible, notification must be given as soon as possible.
ARTICLE 9 - MISCELLANEOUS
9.01 This Agreement supersedes all prior agreements and understandings, both
written and oral between the parties with respect to the subject matter
hereof. This Agreement cannot be amended, changed or supplemented, except
in writing signed by each of the parties hereto.
9.02 This Agreement may be executed in several counterparts, each of which
shall be deemed to be an original.
9.03 All notices which are required or may be given pursuant to this Agreement
shall be sufficient upon receipt, if given in writing and delivered by
hand, by electronic media, or by registered or prepaid addressed as
follows:
TO GILEAD: Gilead Sciences, Inc.
000 Xxxxxxxx Xxxxx
Xxxxxx Xxxx, XX 00000
Attn: General Counsel
Phone: (000) 000-0000
Fax: (000) 000-0000
23
TO ROCHE: Roche Laboratories Inc.
000 Xxxxxxxxx Xxxxxx
Xxxxxx, Xxx Xxxxxx 00000
Attention: Corporate Secretary
Phone: (000) 000-0000
Fax: (000) 000-0000
The address of either party set forth above may be changed from time to
time by written notice in the manner prescribed herein from the party
requesting the change. A notice sent by ordinary mail or a notice not
given in writing shall be effective upon receipt, but only if
acknowledged in writing by a duly authorized representative of the party
to whom it was sent or given or otherwise upon clear evidence of receipt.
9.04 None of the parties hereto may assign any part or all of this Agreement or
the benefit thereof or any right or obligation thereunder to any other
entity or individual without prior written consent of the other party. Any
purported assignment in violation of the preceding sentence shall be void.
9.05 This Agreement shall be construed, regulated and administered and governed
in all respects under and in accordance with the law of the State of New
Jersey.
9.06 Except to the extent that a party may have otherwise agreed in writing,
no waiver by such party of any breach by any other party of any of the
other party's obligations, agreements or covenants hereunder shall be
deemed to be a waiver by such first party of any subsequent or other
breach of the same or any other obligation, agreement or covenant; nor
shall any forbearance by a party to seek a remedy for any breach by
another be deemed a waiver by said party of its rights or remedies with
respect to such breach or of any subsequent or other breach of the same or
any other obligation, agreement or covenant.
9.07 This Agreement shall be binding upon and inure to the benefit of the
parties to this Agreement and their respective successors.
24
9.08 Headings as used in this Agreement are for convenience only and are not to
be construed as having any substantive effect by way of limitation or
otherwise.
9.09 If one or more of the provisions of this Agreement shall, by any court or
under any provision of law, be found to be void or unenforceable, the
Agreement as a whole shall not be affected thereby, and the provisions in
question shall be replaced by an interpretation in conformity with law
which comes closer to effecting the parties' original intention.
IN WITNESS WHEREOF, the parties have caused this Agreement to be executed by
their duly authorized officers effective as of the date first above written.
GILEAD SCIENCES, INC. ROCHE LABORATORIES INC.
By: /s/ Xxxx Xxxxx By: /s/ Xxxxxx Xxxxxxxx
-------------------------- --------------------------
Title: VP, CPO & General Counsel Title: Assistant Secretary
-------------------------- -----------------------
Date: Sept. 27, 1996 Date: September 27, 1996
-------------------------- ------------------------
25
