[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
Exhibit 10.27
FIRST AMENDMENT TO CELLCEPT(R) COLLABORATION AND PROMOTION AGREEMENT
This First Amendment to Cellcept(R) COLLABORATION AND PROMOTION AGREEMENT
(the "AMENDMENT") is entered into as of February 4, 2005 (the "AMENDMENT DATE"),
by and among, on the one hand, Aspreva Pharmaceuticals S.A., a Swiss corporation
having offices at Rue Jacquet-Droz 32, 2301 La Chaux-de-Fonds, Neuchatel,
Switzerland ("ASPREVA"), a subsidiary of Aspreva Pharmaceuticals Corporation
("ASPREVA CANADA"), and on the other hand, Hoffmann-La Roche Inc., a New Jersey
corporation having offices at 340 Kingsland Street, Nutley, New Jersey 07110 and
F. Hoffmann-La Roche Ltd, having offices at Grenzacherstrasse 124, CH-4070
Basel, Switzerland (collectively, "ROCHE"). Both Aspreva and Roche are referred
to individually as a "PARTY" and collectively as the "PARTIES."
WHEREAS, Roche and Aspreva have entered into that certain CellCept(R)
Collaboration and Promotion Agreement, effective as of July 18, 2003, providing
for the development, and if successful, marketing and promotion by Aspreva of
Roche's proprietary drug CellCept(R) (mycophenolate mofetil) for the treatment
of autoimmune diseases (the "ORIGINAL AGREEMENT"); and
WHEREAS, the Parties, in compliance with the Original Agreement, have each
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BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
appointed a Finance Liaison, and such Finance Liaisons have agreed in principal
to certain modifications to the method by which Roche is to make payments to
Aspreva under Article 8 of the Original Agreement; and
WHEREAS, Roche and Aspreva now desire to amend the Original Agreement with
respect to certain provisions thereof as recommended by the Finance Liaisons;
NOW THEREFORE, in consideration of the premises and the mutual covenants
and agreements contained in this Amendment, and for other good and valuable
consideration, the receipt and sufficiency of which signing this Amendment
acknowledge, the Parties, intending to be legally bound, do hereby agree as
follows:
1. Delete Section 1.15 in its entirety and replace with the following:
1.15 "BASELINE RESIDUAL SALES" (BRS(1)) shall mean one hundred
thirty-four million (134,000,000) CHF (and pro rata for any part of a
year), which amount shall be subject to adjustment after the Effective Date
as provided in Section 8.7. In any event, Baseline Residual Sales shall not
exceed one hundred seventy-eight million (178,000,000) CHF.
2. Delete Section 1.25 "ESTIMATED INCREMENTAL RESIDUAL SALES" in its entirety.
3. Delete Section 1.43 "PROJECTED GLOBAL TRACKED SALES" in its entirety.
4. Amend ARTICLE 1 to add the following new definitions:
- ---------------
(1) For ease of cross-reference, equivalent variables in the Approved Model have
been listed as underlined acronyms following the defined terms.
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BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
"APPROVED MODEL" shall mean the financial model for the calculation of
Initial Quarterly Payments and Audited Royalties in accordance with this
Agreement, a copy of which is attached hereto as Schedule A.
"AUDITED INCREMENTAL RESIDUAL SALES" (AIRS) shall be calculated, for a
particular quarter, as follows:
AIRS = MNS - MTS - QBRS,
where "AIRS" is Audited Incremental Residual Sales; "MNS" is MAT Net Sales
for such quarter; "MTS" is the MAT Tracked Sales for such quarter; and
"QBRS" is the Quarterly Baseline Residual Sales.
"AUDITED QUARTER" shall mean, with respect to a given calendar
quarter, the calendar quarter ending [ * ] prior to the end of that
calendar quarter. For example, for the quarter ending March 31, 2007, the
Audited Quarter would be [ * ].
"AUDITED ROYALTY" (AR) shall equal 50% of the Audited Incremental
Residual Sales.
"COLLAR" shall equal Four Million (4,000,000) CHF, subject to
modification by the JC from time to time pursuant to Section 8.2(c).
"GLOBAL TRACKED NET SALES" (GTS) shall mean, for a given time period,
those Net Sales in the Territory determined to have resulted from purchases
of the Product for use in Transplant Indications through an audit conducted
in
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BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
accordance with the then-applicable Sales Tracking Methodology, as provided
in Section 8.5.
"GLOBAL TRACKED SALES PROXY" (GTSP) means, with respect to a given
calendar quarter, the ratio of [ * ] to [ * ] for the quarter ending [ * ]
prior to the end of such calendar quarter. For example, for the quarter
ending March 31, 2007, Global Tracked Sales Proxy would be equal to the
ratio of [ * ] to [ * ] for [ * ].
"INITIAL QUARTERLY PAYMENT" (IQP) shall have the meaning set forth in
Section 8.1(a).
"MAT NET SALES" (MNS) shall mean, with respect to a particular
quarter, the [ * ] quarterly Net Sales for such quarter obtained by [ * ]
Net Sales from such quarter [ * ] to obtain a [ * ] and then [ * ] by
[ * ]. For example, the MAT Net Sales for Q2 of 2006 would be [ * ].
"MAT TRACKED SALES" (MTS) shall mean, with respect to a particular
quarter, the [ * ] quarterly Global Tracked Net Sales for such quarter
obtained by [ * ] Global Tracked Net Sales from such quarter [ * ] to
obtain a [ * ] and then [ * ] by [ * ]. For example, the MAT Tracked Sales
for Q2 of 2006 would be [ * ].
"OFFSET VALUE" (OV) shall be set initially at [ * ] CHF. In the event
that the differential between the Audited Royalty and the Initial Royalty
Payment for a particular quarter, as calculated under Section 8.2(b), is
greater than the [ * ]
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COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
applicable to such quarter, the Offset Value shall be adjusted in
accordance with following formula:
[ * ],
where "OV" is the Offset Value for such calendar quarter; and "Overage" is
equal to the amount by which the [ * ] the [ * ] and the corresponding
[ * ] for the [ * ] relevant to such calendar Quarter exceeds [ * ] (which
shall be [ * ] if such [ * ] is in Roche's favor and [ * ] if such [ * ] is
in Aspreva's favor). After [ * ] (or sooner if agreed by the Parties), the
JC and/or the Finance Committee will revisit in good faith the calculation
of the Offset Value and if it is determined that a change to such
calculation is appropriate, then, subject to their mutual agreement, the
Parties will amend the Agreement accordingly.
"QUARTERLY BASELINE RESIDUAL SALES" (QBRS) shall mean Baseline
Residual Sales for the then current calendar year multiplied by 0.25.
"QUARTERLY INCREMENTAL RESIDUAL SALES" (QIRS) shall be calculated, for
each calendar quarter, as follows:
QIRS = {MNS x (1 - GTSP)} - QBRS,
where "QIRS" is Quarterly Incremental Residual Sales; "MNS" is MAT Net
Sales for such quarter; "GTSP" is the Global Tracked Sales Proxy for such
quarter; and "QBRS" is the Quarterly Baseline Residual Sales.
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BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
"SALES TRACKING METHODOLOGY" shall have the meaning set forth in
Section 8.5.
5. The Parties acknowledge and agree that the document attached as Annex A to
this Amendment accurately describes the basis for the initial value of the
Offset Value set forth above.
6. Delete ARTICLE 8 in its entirety and replace with the following:
ARTICLE 8
ROYALTIES AND ACCOUNTING
8.1 INITIAL ROYALTY PAYMENTS TO ASPREVA. Beginning with the quarter
commencing April 1, 2005, and continuing each calendar quarter until the
end of the Term (such period, the "ROYALTY TERM"), Roche shall owe to
Aspreva royalty payments as follows:
(a) INITIAL QUARTERLY PAYMENT. Beginning with the quarter
commencing April 1, 2005, Roche shall owe to Aspreva a royalty payment
equal to the [ * ] (adjusted pro-rata for any partial quarters) plus fifty
percent (50%) of the Quarterly Incremental Residual Sales for such quarter
or portion thereof (the "INITIAL QUARTERLY PAYMENT").
(b) CALCULATION OF GLOBAL TRACKED SALES PROXY AND INITIAL
QUARTERLY PAYMENT. Roche shall determine the Global Tracked Sales Proxy for
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BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
a particular quarter, and shall calculate the Initial Quarterly Payment for
such quarter, within [ * ] business days after the end of such calendar
quarter.
(c) PAYMENT. Roche shall pay to Aspreva the Initial Quarterly
Payment set forth in Section 8.1(a) in accordance with Section 8.3.
8.2 PAYMENTS BASED UPON AUDITED INCREMENTAL RESIDUAL SALES.
(a) CALCULATION OF MAT TRACKED SALES. For the calendar quarter
ending [ * ] after the end of the first calendar quarter in respect to
which an Initial Quarterly Payment is owed, and for each calendar quarter
thereafter during the Term (the "RECENT QUARTER"), Roche shall calculate
the MAT Tracked Sales for the Audited Quarter relevant the Recent Quarter,
using the results of the Sales Tracking Methodology for [ * ] and shall
provide such calculation to Aspreva in writing within [ * ] business days
after the end of the Recent Quarter. Roche shall in addition present such
calculation to the Finance Subcommittee for review and approval (the "AUDIT
MEETING") as soon as reasonably possible.
(b) DETERMINATION OF AUDITED ROYALTY. Roche shall calculate the
Audited Incremental Residual Sales for such Audited Quarter (using the MAT
Tracked Sales approved in the Audit Meeting, if available) and shall
calculate the Audited Royalty, and the Parties shall proceed as provided
below:
(i) if the Audited Royalty for such Audited Quarter is
greater than the Initial Royalty Payment paid with respect to the Audited
Quarter, then Roche shall owe to Aspreva an amount equal to such
differential amount,
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COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
but in no event shall Roche owe to Aspreva under this Section 8.2 more than
the Collar (such payment to Aspreva referred to as the "ASPREVA
DIFFERENTIAL PAYMENT"). By way of example, assuming that the Collar remains
at the initial value of Four Million (4,000,000) CHF, if the Initial
Royalty Payment was Twenty Million (20,000,000) CHF, and the Audited
Royalty was Twenty-Five Million (25,000,000) CHF, Roche would owe to
Aspreva Four Million (4,000,000) CHF;
(ii) if the Audited Royalty for such Audited Quarter is less
than the Initial Royalty Payment for such Audited Quarter, then Aspreva
shall owe to Roche an amount equal to such differential amount, but in no
event shall Aspreva owe to Roche under this Section 8.2 more than the
Collar (such payment to Roche referred to as the "ROCHE DIFFERENTIAL
PAYMENT"). By way of example, assuming that the Collar remains at the
initial value of Four Million (4,000,000) CHF, if the Initial Royalty
Payment was Twenty-Five Million (25,000,000) CHF, and the Audited Royalty
was Twenty Million (20,000,000) CHF, Aspreva would owe to Roche Four
Million (4,000,000) CHF.
(c) The JC may elect at any point to change the value of the
Collar, which, if the JC so elects, shall become effective immediately upon
such election.
8.3 REPORTS; PAYMENTS
(a) ROCHE REPORT. Within [ * ] days after the end of each
calendar quarter as to which a payment is due under Section 8.1 and/or
Section
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BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
8.2, Roche shall submit to Aspreva an updated version of the Approved
Model, which shall incorporate the most recent data available to Roche and
shall be accompanied by all related calculations necessary for
substantiating the calculation of the Initial Quarterly Payment for such
calendar quarter and the Audited Royalty for the Audited Quarter relative
to such calendar quarter. In connection with such updated model, Roche
shall certify that the determination of the MAT Tracked Sales was performed
based on numbers calculated in accordance with the then-current Sales
Tracking Methodology.
(b) PAYMENTS. Along with delivery of the report referred to in
Section 8.3(a) above, Roche agrees to pay to Aspreva an amount equal to
either (i) the Initial Royalty Payment plus the Aspreva Differential
Payment, or (ii) the Initial Royalty Payment minus the Roche Differential
Payment, as appropriate.
(c) REVIEW OF AUDITED DATA. Notwithstanding the Audit Meeting,
Aspreva shall have a period of [ * ] after receipt to review, comment upon,
or otherwise object in writing or inquire as to the information provided by
Roche pursuant to Section 8.3(a), it being understood that any such
comments or objections shall be directed to the accurate implementation of
the Sales Tracking Methodology and the auditing process as described in
Section 8.2, and not to the utility or appropriateness of the Sales
Tracking Methodology itself. Upon receipt of any such objections or
questions, Roche shall supply to Aspreva such information as Aspreva
reasonably requests. In the event an error is identified, Roche shall have
[ * ] business days to re-run the determination of
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BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
Global Tracked Net Sales or MAT Tracked Sales, or re-calculate the Audited
Royalty or the Aspreva Differential Payment or the Roche Differential
Payment, as the case may be, and shall either remit any additional payment
owed Aspreva, or shall have the right to credit any overpayment to Aspreva
against the next payment owed Aspreva under Section 8.2. This Section
8.3(c) shall not be construed as diminishing Aspreva's rights under Section
8.13 (Accounting; Audits).
8.4 REASSESSMENT OF RECONCILIATION PROCESS. In the event that, for
each of [ * ] quarters, the differential between the Audited Royalty and
the Initial Royalty Payment for such quarter, as calculated under Section
8.2(b), is greater than the Collar(s) applicable to such quarters [ * ],
then:
(a) Notwithstanding Section 8.2(b), the Aspreva Differential
Payment or the Roche Differential Payment, as the case may be, for [ * ]
such [ * ] quarters shall not be limited to the Collar and instead shall be
[ * ].
(b) Either Party shall have the right to demand a meeting of the
JC or the Finance Subcommittee, as the case may be, and the Parties'
representatives shall reassess the Sales Tracking Methodology, and/or the
method of calculating the Initial Quarterly Payment, as set forth in
Section 8.1, and the Parties shall meet in good faith to determine a more
appropriate methodology so as to ensure fair and accurate compensation to
the Parties under this Agreement by tracking as accurately as possible
purchases of the Product in the Transplant Indications and by estimating as
closely as is
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BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
reasonably possible the initial royalty payments to Aspreva in light of the
fact that audited information regarding any given calendar quarter is not
available at the end of such calendar quarter, but only subsequent thereto.
If the JC fails to agree on a different methodology proposed by either
Party by the time that the next Initial Quarterly Payment must be
calculated, the Sales Tracking Methodology and the method for paying
royalty payments and the reconciliation thereof then in effect shall
continue to be used, except that, unless and until the JC agrees on a
different methodology, the Aspreva Differential Payment or the Roche
Differential Payment, as the case may be, for each quarter shall not be
limited to the Collar and instead shall be [ * ].
8.5 SALES TRACKING METHODOLOGY.
(a) METHODOLOGY. For the purpose of the determination of Global
Tracked Net Sales, the Global Tracked Sales Proxy, and MAT Tracked Sales,
Roche shall utilize a defined methodology to determine which portion of Net
Sales in the Territory resulted from purchases of the Product for use in
the Transplant Indications (the "SALES TRACKING METHODOLOGY"). Aspreva and
Roche agree that the Sales Tracking Methodology shall initially be such
methodology as is described in Schedule 8.5 to this Agreement, and may
modified by the JC pursuant to Section 8.5(b).
(b) MODIFICATIONS TO METHODOLOGY. On a periodic basis [ * ], the
JC shall review the current Sales Tracking Methodology and shall either
affirm such Sales Tracking Methodology or elect to adopt a different or
modified
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BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
Sales Tracking Methodology. If the JC elects to adopt a different or
modified Sales Tracking Methodology, it shall become effective for the
Audited Quarter with respect to the quarter in which such election occurs,
and Schedule 8.5 shall be so amended to substitute such newly agreed-upon
Sales Tracking Methodology. If the JC fails to agree on a different Sales
Tracking Methodology proposed by either Party, the Sales Tracking
Methodology then in effect shall continue to be used. Notwithstanding the
foregoing, it is understood and agreed by the Parties that each shall have
the right, at its own expense, to undertake such market research and
analysis, including "probes" or sampling of patient data, physician
prescribing habits and the like (the "NEW SALES TRACKING DATA") or
otherwise propose modifications to the Sales Tracking Methodology at any
time during the Term, and to present such data or otherwise propose
modifications to the Sales Tracking Methodology to the JC to enhance the
validity or reliability of the Sales Tracking Methodology. It shall be the
JC's continuing obligation to review any such New Sales Tracking Data in
good faith, with the overriding obligation to ensure fair and accurate
compensation to the Parties under this Agreement by tracking as accurately
as reasonably possible, purchases of the Product in the Transplant
Indications, balancing the desirability of increased accuracy against the
costs of obtaining same. In the event that the JC adopts a new Sales
Tracking Methodology that incorporates New Sales Tracking Data proposed by
a Party, such proposing Party bears the burden of payment of any
incremental costs of obtaining such New Sales Tracking Data;
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COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
provided, however, that after [ * ], the Parties will share such costs
[ * ] to the extent such costs are then prospective.
8.6 INTENTIONALLY DELETED.
8.7 ADJUSTMENTS TO BASELINE RESIDUAL SALES.
(a) CHANGES IN AVERAGE UNIT SELLING PRICE. Commencing January
2004, Roche shall calculate the Average Unit Selling Price and communicate
same to Aspreva in writing. On an annual basis thereafter, Roche shall
calculate the increase or decrease in the Average Unit Selling Price from
the prior twelve month period, and the Parties shall adjust Baseline
Residual Sales upward or downward, as the case may be, by that same
percentage. On or before January 31st of each year, Roche shall provide to
Aspreva a report listing (i) such increase or decrease in the Average Unit
Selling Price and (ii) the new Baseline Residual Sales figure for the
then-current year, both calculated pursuant to this Section 8.7(a).
(b) PRODUCT RECALLS AND WITHDRAWALS. In the event that, due to a
Product recall or withdrawal, the Product is no longer sold in such
country, then Baseline Residual Sales shall be adjusted downward to offset
the loss of sales in such country. Such adjustment for such country shall
be at that percentage level set forth in Schedule 8.7(b) opposite the name
of such country. For example, in the event the Product were no longer being
sold in Germany,
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BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
Baseline Residual Sales would be reduced by [ * ], and would only be
subject to upward adjustment thereafter as provided in Section 8.7(a).
[ * ].
(c) TERMINATION BY ASPREVA. In the event that Aspreva terminates
this Agreement with respect to a particular country in the Territory as
provided in Section 14.2, then the Territory shall be defined thereafter as
excluding such country for purposes of calculating Net Sales, and Baseline
Residual Sales shall be adjusted downward to offset the loss of sales in
such country. Such adjustment for such country shall be equal to that
percentage level set forth in Schedule 8.7(b) opposite the name of country.
For example, in the event the Product were no longer being sold in Germany,
Baseline Residual Sales would be reduced by [ * ], and would only be
subject to upward adjustment thereafter as provided in Section 8.7(a).
8.8 FINANCE LIAISON. No later than thirty (30) days prior to the start
of the Royalty Term, each Party shall designate a Finance Liaison
responsible for overseeing and facilitating the exchange of information
contemplated under this Article 8. Either Party may replace its Finance
Liaison at any time upon thirty (30) days prior written notice to the other
Party.
8.9 CURRENCY AND CONVERSION. All payments under this Agreement shall
be in Swiss Francs. For the purpose of computing Net Sales for Product sold
in a currency other than Swiss Francs, Roche shall convert the amount of
Net Sales in foreign currencies as computed in accordance with Roche's then
current standard practices.
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COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
8.10 INTEREST. In the event that Roche is late in paying to Aspreva
any amounts due under this Agreement within the applicable time period set
forth herein, such payment shall bear interest at the lesser of (a) [ * ]
as reported by [ * ] (or a successor or similar organization) from time to
time and (b) the maximum amount permitted by applicable law.
8.11 TAXES.
(a) COOPERATION AND COORDINATION. The Parties acknowledge and
agree that it is their mutual objective and intent to minimize, to the
extent feasible, taxes payable with respect to their collaboration efforts
under this Agreement and that they shall use their best efforts to
cooperate and coordinate with each other to achieve such objective.
(b) PAYMENT OF TAX. A Party receiving a payment pursuant to this
Article 8, or deemed to receive a payment as a result of the
cross-licensing arrangement under Article 2, shall pay any and all taxes
levied on such payment or deemed payment. If applicable laws or regulations
require that taxes be deducted and withheld from a payment made pursuant to
this Article 8, the remitting Party shall (i) deduct those taxes from the
payment; (ii) pay the taxes to the proper taxing authority; and (iii) send
evidence of the obligation together with proof of payment to the other
Party within sixty (60) days following that payment.
(c) TAX RESIDENCE CERTIFICATE. A Party (including any party to
whom this Agreement may be assigned as permitted under Section 16.2)
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COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
receiving a payment pursuant to this Article 8 shall provide the remitting
Party certification from the revenue authorities of a jurisdiction (a "TAX
RESIDENCE CERTIFICATE") that it is a tax resident of that jurisdiction if
such receiving Party wishes to claim the benefits of an income tax treaty
to which that jurisdiction is a party. Upon the receipt thereof, any
deduction and withholding of taxes shall be made at the appropriate treaty
tax rate.
(d) ASSESSMENT. Either Party may, at its own expense, protest any
assessment, proposed assessment, or other claim by any governmental
authority for any additional amount of taxes, interest or penalties or seek
a refund of such amounts paid if permitted to do so by law. The Parties
shall cooperate with the other in any protest by providing records and such
additional information as may reasonably be necessary for a Party to pursue
such protest.
8.12 BLOCKED CURRENCY. If by reason of law Roche is unable to convert
to Swiss Francs a portion of the amount due by Roche under this Agreement,
then Roche shall notify Aspreva in writing and Aspreva shall have the right
to receive such portion and, upon written request from Aspreva, Roche shall
pay to Aspreva such portion, in the currency of any other country
designated by Aspreva and legally available to Roche.
8.13 ACCOUNTING; AUDITS.
(a) RECORDS. Roche agrees to keep full, clear, and accurate
records for a period of at least three (3) years, or such longer period as
may
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COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
coincide with Roche's internal records retention policy, setting forth
sales of the Product in the Territory during the Term in sufficient detail
to permit Aspreva to confirm the accuracy of (i) Roche's determination of
Global Tracked Net Sales pursuant to the Sales Tracking Methodology and
(ii) the calculation of royalty payments and other compensation payable to
Aspreva under this Agreement.
(b) AUDIT. Roche further agrees to permit Aspreva to engage
Roche's independent, certified public accountant, on behalf of Aspreva, to
examine by way of an audit conducted in accordance with IAS, such of its
books and records related to the calculations set forth in this Article 8,
including all data used in conducting the Sales Tracking Methodology and in
calculating Global Tracked Net Sales, but in any event no more than once in
any given calendar year. Aspreva shall have a right to request from the
independent certified public accountant full access to review all work
papers and supporting documents pertinent to such audit. If Aspreva
reasonably believes, after reviewing information received from Roche's
independent public accountant, that an additional audit is appropriate to
address an apparent discrepancy with respect to Roche's calculation of Net
Sales or other calculations set forth in this Article 8, Aspreva shall have
the right, by an audit specialty firm acceptable to Roche, employed by
Aspreva and at Aspreva's own expense, to perform such necessary audit
procedures.
(c) COSTS OF AUDIT. Aspreva shall bear the cost of any audit
under this Section 8.13, except in the event that the results of the audit
reveal an
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COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
underpayment of the amounts described in this Article 8 by [ * ] or more
over the period being audited, in which case Roche shall pay all costs of
such examination. In the event that such examination concludes that
additional amounts are owed to Aspreva, Roche shall pay any such additional
amounts within thirty (30) days of the date that Roche receives the written
report so concluding. In the event that such examination concludes that
there has been an overpayment with respect to amounts paid to Aspreva, the
excess (after deducting the cost of the examination) shall be credited to
Roche against future payments required by this Article 8.
7. The Parties acknowledge and agree that the Sales Tracking Methodology will
be implemented [ * ] described on Schedule B to this Amendment, and the
Parties shall [ * ] after the Amendment Date to [ * ] of the [ * ]
accordingly. In no event shall any [ * ] pursuant to this Section 7
disadvantage either Party with respect to the financial arrangement of the
Agreement as hereby amended.
18
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
IN WITNESS WHEREOF, the parties hereto have caused this Amendment to be
executed by their duly authorized officers as of the date first above written.
ASPREVA PHARMACEUTICALS S.A. F. HOFFMANN-LA ROCHE LTD
By: /s/ Kalust Zorik By: /s/ D. P. Moorhead
--------------------------------- ---------------------------------
Name: Kalust Zorik Name: D. P. Moorhead
Title: Board Member Title: Head of Pharma Finance
By: /s/ P. Comte By: /s/ Stefan Arnold
--------------------------------- ---------------------------------
Name: Pierre Comte Name: Stefan Arnold
Title: Director Title: Deputy Director
HOFFMANN-LA ROCHE INC.
By: /s/ George W. Johnston
---------------------------------
Name: George W. Johnston
Title: Vice President
19
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
SCHEDULE A
[ * ]
20
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
SCHEDULE B
[ * ]
21
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.