Exhibit 10.6
A mark of [***] in the text of this Exhibit
indicates that confidential material has been omitted.
This Exhibit, including the omitted portions,
has been filed separately with the Secretary of the Securities and
Exchange Commission pursuant to an application requesting
confidential treatment under Rule 24b-2 of the Securities Exchange
Act of 1934.
AMENDED AND RESTATED DISTRIBUTION
AGREEMENT
This Amended and Restated
Distribution Agreement ( “AGREEMENT” ) is
entered into as of February 23, 2005 (the “EFFECTIVE
DATE” ) by and between MedImmune, Inc., a Delaware
corporation, having its principal place of business at One
MedImmune Way, Gaithersburg, MD 20878 (
“MEDIMMUNE” ), and Abbott International LLC, a
Delaware limited liability corporation (
“ABBOTT” ), having its principal place of
business at 100 Abbott Park Road, Abbott Park, IL 60064.
Recitals
:
A.
ABBOTT and MEDIMMUNE entered into a
Distribution Agreement, dated December 1, 1997 (as amended as
of April 28, 1999, October 8, 1999 and July 1, 2003,
the “ORIGINAL AGREEMENT” ), for the distribution
of MEDI-493 (palivizumab), a humanized antibody directed against
respiratory syncytial virus ( “RSV”
).
B.
MEDIMMUNE and ABBOTT desire to amend
the ORIGINAL AGREEMENT to include the distribution of additional
humanized antibody products directed against RSV and to further
amend and restate the ORIGINAL AGREEMENT in its entirety as set
forth in this AGREEMENT.
In consideration of the mutual
promises and other good and valuable consideration, the parties
hereby amend and restate the ORIGINAL AGREEMENT as
follows:
Agreement
:
1.
DEFINITIONS
.
In addition to the terms defined
above and other terms defined in other Sections of this AGREEMENT
and Exhibit 3.2 , the following terms when capitalized shall
have the meanings set forth below for purposes of this
AGREEMENT.
1.1
“AFFILIATE” shall mean
any corporation or other business entity that directly or
indirectly controls, is controlled by, or is under common control
with a PARTY. Control means ownership or other beneficial
interest in fifty percent (50%) or more of the voting stock or
other voting interest of a corporation or other business entity the
term, provided however that, the term shall specifically exclude
TAP Pharmaceutical Products Inc., TAP Finance Inc., and TAP
Pharmaceuticals Inc.
1.2
“cGMP” shall mean the
quality systems and current good manufacturing practices for the
manufacture of the PRODUCT required by the REGULATORY AUTHORITIES
in any country in the MAJOR MARKET, as amended from time to
time.
1.3
“CALENDAR QUARTER” shall
mean the period of three consecutive calendar months ending on
March 31, June 30, September 30 or December 31
of any CONTRACT YEAR, as the case may be; provided ,
however , that the first CALENDAR QUARTER shall commence on
the EFFECTIVE DATE hereof and shall end on March 31, 2005, and
the last CALENDAR QUARTER shall commence on the date following the
last day of the immediately prior CALENDAR QUARTER and end on the
date of the expiration of the TERM.
1.4
“COMMERCIALLY REASONABLE
EFFORTS” shall mean those efforts of a PARTY which are
consistent with those utilized by such PARTY to achieve the intent
and
objectives of the PARTIES under this
AGREEMENT in good faith, taking into account all factors that
impact the manufacturing, development, marketing and sales of the
PRODUCTS, as applicable, which are commercially reasonable in the
context of the PRODUCTS and the marketplace, unless the other PARTY
can demonstrate that such PARTY’s efforts deviate
meaningfully from the industry norm.
1.5
“CONTRACT YEAR” shall
mean July 1 of a calendar year through June 30 of the
following calendar year, except that, solely for the purposes of
calculating the amounts due under Section 3.8 , the
term “CONTRACT YEAR” shall mean the 12 month period
commencing on December 1 of each calendar year and ending on
November 30 of the immediately following calendar year;
provided, however , that the first CONTRACT YEAR shall start
on the EFFECTIVE DATE and end on June 30, 2005 (or
November 30, in the case of Section 3.8 ) and that
the last CONTRACT YEAR shall end on the last day this AGREEMENT
remains in effect.
1.6
“COST OF GOODS” shall
mean the fully allocated cost to manufacture each UNIT of the
PRODUCTS, determined in a reasonable manner consistent with
MEDIMMUNE’s normal internal accounting practices and in
accordance with generally accepted accounting principles
(“GAAP”), which includes but is not limited to: (a)
direct labor (salaries, wages and employee benefits); (b) direct
materials; (c) operating costs of building and equipment used in
connection with the manufacture of PRODUCT; (d) allocated
depreciation and repairs and maintenance; (e) quality and
in-process control; (f) an allocation of overhead costs incurred in
connection with the manufacturing of PRODUCT, including: raw
material supply and manufacturing administration and management,
materials management, storage and handling; and manufacturing and
employee training; (g) any charges for obsolescence, out of date
product, spoilage, scrap or rework costs; (h) insurance costs; and
(i) the cost of packaging and labeling, if applicable. To the
extent that the manufacturing of the PRODUCTS is performed for
MEDIMMUNE by a THIRD PARTY, amounts paid to such THIRD PARTY shall
be included in COST OF GOODS in lieu of the items specified in (a)
through (i) above. No later than sixty (60) days following
the start of each CONTRACT YEAR during the TERM of this AGREEMENT,
MEDIMMUNE shall provide ABBOTT, in writing, with the COST OF GOODS
for each presentation of the PRODUCT that will be supplied by
MEDIMMUNE.
1.7
“DEVELOPMENT COMMITTEE”
shall have the meaning set forth in Section 6.6
.
1.8
“FDA” shall mean the
United States Food and Drug Administration and any successor
regulatory authority in the United States of America.
1.9
“FIRM ORDER” shall have
the meaning set forth in Section 5.1 .
1.10
“FTE RATE” shall mean
the pro rata share of the fully burdened cost of a sales
representative, per annum, based on time spent on the promotion of
NUMAX in relation to the total time spent on all products promoted
by such sales representative, comprising of the wages, bonuses,
incentives, car expenses, other detailing costs typically
associated with the promotion of a pharmaceutical product
(including, but not limited to, expenses associated with training,
promotional materials, travel and entertainment) and overhead costs
reasonably allocable to such activities, as applicable in the
country in the TERRITORY in which NUMAX will be co-promoted by
MEDIMMUNE.
2
1.11
“LAUNCH” shall mean the
date of the first commercial sale of a PRODUCT sold on arm’s
length terms to a THIRD PARTY by ABBOTT or any of its AFFILIATES in
any country within the TERRITORY after the REGULATORY APPROVAL
required for the marketing and sale of such PRODUCT in such country
within the TERRITORY has been obtained. Sales for clinical
trial purposes shall not be considered a LAUNCH. For clarity,
a LAUNCH of a PRODUCT in the TERRITORY shall only be deemed to
occur once upon the first commercial sale in the TERRITORY
regardless of the number of countries in the TERRITORY in which
such PRODUCT is approved and marketed.
1.12
“MAJOR MARKET” shall
mean any of the following countries: [***], and, collectively, the
MAJOR MARKETS, subject to adjustment as set forth in
Section 14.3 .
1.13
“NET SALES” shall mean,
with respect to any PRODUCT, that sum determined by deducting from
the gross amount invoiced in the applicable period by ABBOTT or
ABBOTT’s AFFILIATES for such PRODUCT sold for use in the
TERRITORY in an arms length transaction to THIRD PARTIES: (a)
transportation, importation, insurance and other handling charges
to the extent included in the billing; (b) trade, quantity or cash
discounts, to the extent allowed; (c) credits or allowances, if
any, given or made on account of price adjustments, or returns, to
the extent made; (d) any and all Federal, state or local government
rebates, whether in existence now, or enacted at any time during
the term of this AGREEMENT, to the extent made; (e) any sales, use,
value-added, excise or similar tax or other governmental charge
upon or measured by the production, sale, transportation, delivery
or use of such PRODUCT; and (f) a reasonable allowance for bad
debt; in each case determined in accordance with ABBOTT’s
normal internal accounting practices and GAAP.
1.14
“NUMAX” shall mean the
product candidate being developed by MEDIMMUNE, known as of the
EFFECTIVE DATE as MEDI-524, including any functional derivative,
delivery form, dosage form, formulation, improvement or
presentation of such product candidate developed by or on behalf of
MEDIMMUNE following the EFFECTIVE DATE.
1.15
“PHASE III CLINICAL
TRIAL” shall mean the Phase III clinical trial for NUMAX
ongoing as of the EFFECTIVE DATE (designated by MEDIMMUNE as of the
EFFECTIVE DATE as STUDY #MI-CP110).
1.16
“PARTY” or
“PARTIES” shall mean ABBOTT and/or MEDIMMUNE, as the
case may be.
1.17
“PATENT” shall mean the
patent and patent applications listed on Exhibit 10.8 , and
any and all reissues, extensions, substitutions, reexaminations,
supplemental protection certificates, continuations,
continuations-in-part or divisions of or to any of such patents and
patent applications.
1.18
“PRODUCT(S)” shall mean
SYNAGIS and/or NUMAX.
1.19
“REGISTRATION FILES”
means the following documents and related correspondence with
REGULATORY AUTHORITIES: (a) REGULATORY FILINGS; (b) Drug Master
Files (the “DMF’s”) and Registration
Dossier for the PRODUCTS; (c) labeling for all dosage forms of the
PRODUCTS; (d) all clinical raw data concerning PRODUCT, expert
reports, pre-clinical and clinical reports; (e) stability study
reports; (f) existing
3
specifications (including copies of
validation of analytical methods); (g) formulations data included
in the registration dossier for the PRODUCT; (h) any adverse event
and pharmacovigilance reports; and (i) a summary of any outstanding
regulatory issues.
1.20
“REGULATORY APPROVAL”
shall mean the applicable technical, medical and scientific
licenses, registrations, authorizations and approvals required for
marketing and/or use of the PRODUCTS in each country in the
TERRITORY, including, without limitation, approvals of Biologics
License Applications (BLA) or equivalent applications filed with
REGULATORY AUTHORITIES in the TERRITORY, but excluding pricing,
reimbursement or labeling approvals except to the extent required
by a REGULATORY AUTHORITY in any country in the TERRITORY for the
distribution, marketing, promotion, offer for sale, use, import or
sale of PRODUCTS. For the avoidance of doubt, an
“approvable letter” (or its equivalent) issued by a
REGULATORY AUTHORITY shall not be considered a REGULATORY
APPROVAL.
1.21
“REGULATORY AUTHORITY”
shall mean the FDA and any national, supra-national (e.g., the
European Commission, the Council of the European Union, or the
European REGULATORY AUTHORITY for the Evaluation of Medicinal
Products), regional, state or local regulatory authority,
department, bureau, commission, council or other governmental
entity.
1.22
“REGULATORY FILINGS”
shall mean a pre-market approval application and/or any other
filings or dossier as may be required by REGULATORY AUTHORITIES to
obtain or maintain REGULATORY APPROVALS for sale, use or marketing
of any PRODUCT.
1.23
“REVERSION DATE” shall
mean, with respect to a REVERSION EVENT, the earlier of: (a)
[***] (or such later date on which ABBOTT declares a REVERSION
EVENT in accordance with Section 3.4 ), (b) [***] years
after the date of occurrence of a REVERSION EVENT defined in
Sections 3.4 (a)(i) through (iv) , or (c) the first
date after occurrence of a REVERSION EVENT defined in
Section 3.4(a)(v) .
1.24
“REVERSION EVENT” shall
have the meaning set forth in Section 3.4 .
1.25
“SPECIFICATIONS” shall
mean the written specifications for ingredients, composition,
sampling, test procedures, process descriptions, in-process
criteria, final release criteria and other information relating to
each of the PRODUCTS. The current SPECIFICATIONS for the
lyophilized formulation of SYNAGIS are attached as Exhibit
A-1 , the SPECIFICATIONS for the liquid formulation of SYNAGIS
are attached as Exhibit A-2 and the SPECIFICATIONS for NUMAX
are attached at Exhibit A-3 .
1.26
“SYNAGIS” shall mean any
and all formulations of the humanized antibody product known as
palivizumab that is marketed in the TERRITORY as of the EFFECTIVE
DATE under the trademark Synagis®, and was previously known as
MEDI-493.
1.27
“TERRITORY” shall mean
all countries of the world except the United States of America and
its territories, possessions and commonwealths, subject to
adjustment as set forth in Section 14.3 .
1.28
“THIRD PARTY” shall mean
a party other than ABBOTT, MEDIMMUNE or their respective
AFFILIATES.
4
1.29
“THIRD PARTY
MANUFACTURER” shall mean, for SYNAGIS, as of the EFFECTIVE
DATE, Boehringer Ingelheim, or such other party that MEDIMMUNE
appoints following the EFFECTIVE DATE for the manufacture of each
of the finished PRODUCTS, in accordance with
Section 7.8 .
1.30
“TRADEMARK” shall mean
the trademark(s) for each of the PRODUCTS (with ownership
determined in accordance with Section 10 ).
1.31
“UNIT” shall mean a 50
mg vial, a 100 mg vial or other presentation of one or more of the
PRODUCTS approved from time to time by the Manufacturing Steering
Committee. For the purpose of any price calculations under this
AGREEMENT, a UNIT shall be deemed to be a 100 mg equivalent vial of
PRODUCT (e.g., a 50 mg vial would be equal to a 0.5 100 mg
equivalent vial).
1.32
“VACCINE” shall mean one
or more biological and/or chemical materials that is or are
designed to elicit an immune response in humans.
2.
GRANT OF RIGHTS
.
2.1
APPOINTMENT AND
ACCEPTANCE .
(a)
During the TERM of this AGREEMENT,
MEDIMMUNE hereby appoints ABBOTT as the exclusive distributor of
each of the PRODUCTS in the TERRITORY. In connection with
such appointment, except as set forth in Section 9 ,
ABBOTT shall exclusively conduct the marketing, promotion, sale and
distribution of: (i) NUMAX for use in the prevention or treatment
of all human, prophylactic and therapeutic, approved indications in
any country within the TERRITORY (including all indications for
which NUMAX is approved following the EFFECTIVE DATE in any country
within the TERRITORY), and (ii) SYNAGIS for use in the prevention
of RSV. For the avoidance of doubt, ABBOTT’s
appointment as the exclusive distributor means that, except as
specifically provided otherwise in this AGREEMENT, MEDIMMUNE shall
neither itself, directly or indirectly, market, promote, sell or
distribute nor grant a THIRD PARTY any right to market, promote,
sell or distribute in any country within the TERRITORY: (x) NUMAX
for any human, prophylactic and therapeutic indication, or (y)
SYNAGIS for the prevention of RSV.
(b)
ABBOTT hereby accepts the
appointment as the exclusive distributor of the PRODUCTS as set
forth in Section 2.1(a) . In connection with such
appointment, ABBOTT agrees that following REGULATORY APPROVAL of a
PRODUCT in each country of the TERRITORY, ABBOTT shall use its
COMMERCIALLY REASONABLE EFFORTS to market, promote, sell and
distribute at least one PRODUCT in each such country and, if NUMAX
is approved in a particular country, then to the extent
commercially viable (considering such factors as the breadth of the
NUMAX label compared to the SYNAGIS label, the relative adverse
event profile of each and the relative reimbursement rates of
each), ABBOTT shall use its COMMERCIALLY REASONABLE EFFORTS to
market, promote, sell and distribute NUMAX in any such
countries.
5
(c)
For clarity, MEDIMMUNE agrees that,
following the LAUNCH of NUMAX in any country in the TERRITORY, for
as long as ABBOTT is actively distributing, marketing, promoting
and selling NUMAX in such country, ABBOTT shall, in its sole
discretion, have the right to cease the marketing, promotion, sale
and distribution of SYNAGIS in such country upon written notice to
MEDIMMUNE and subject to the transition provisions of
Section 5.2 . ABBOTT’s failure to market,
promote, sell or distribute SYNAGIS in any country in the TERRITORY
during the active sale and distribution of NUMAX in such country
shall not entitle MEDIMMUNE to terminate ABBOTT’s exclusive
rights to SYNAGIS in such country under
Section 14.3(c)(i) and shall not entitle MEDIMMUNE to
itself market, promote, sell or distribute SYNAGIS for the
prevention of RSV in any such country or grant any right to market,
promote, sell or distribute SYNAGIS for the prevention of RSV in
any such country to any THIRD PARTY.
(d)
ABBOTT hereby warrants and agrees as
follows: (i) ABBOTT will only sell product for the treatment or
prevention of RSV (including any indication for which NUMAX is
approved in the future) in the TERRITORY which is purchased from
MEDIMMUNE; (ii) ABBOTT will only sell and distribute product for
the treatment or prevention of RSV (including any indication for
which NUMAX is approved in the future) in the TERRITORY as to which
ABBOTT maintains distribution rights under this AGREEMENT; (iii)
ABBOTT will sell and distribute the PRODUCTS in accordance with the
terms and conditions of this AGREEMENT; (iv) ABBOTT will sell each
PRODUCT in the TERRITORY under the TRADEMARK applicable to such
PRODUCT and only as purchased from MEDIMMUNE; and (v) to the extent
commercially reasonable, ABBOTT will sell all PRODUCTS in its
inventory on a first-in, first-out basis (i.e., UNITS of PRODUCT
closest to their expiration date will be sold first).
(e)
ABBOTT agrees that neither ABBOTT
nor an AFFILIATE of ABBOTT shall manufacture, promote, market or
sell, directly or indirectly, or assist any THIRD PARTY in
marketing or selling in the TERRITORY, any [***]. These
restrictions will apply during the term of the AGREEMENT and for
[***] after the termination or expiration of the AGREEMENT, except
in the European Union, where the duration of the restriction is
limited to [***] from the date of entry into force of the
AGREEMENT. Notwithstanding the foregoing, the restrictions
set forth in the preceding two sentences shall not be applicable in
any countries in the TERRITORY to the extent such restrictions are
not permitted under applicable law, but if ABBOTT or an AFFILIATE
of ABBOTT promotes, markets, sells or distributes any [***] in such
countries, MEDIMMUNE shall have the sole right to either terminate
this AGREEMENT or seek to renegotiate the terms of this AGREEMENT
in light of the applicable antitrust laws and regulations (in which
case ABBOTT will negotiate in good faith an appropriate amendment
to this AGREEMENT).
(f)
ABBOTT agrees and acknowledges that
neither ABBOTT nor its AFFILIATES has been granted any rights by
MEDIMMUNE (either under this AGREEMENT or otherwise) to research,
manufacture, develop, market, promote, sell or distribute NUMAX
outside of the TERRITORY or SYNAGIS outside of the TERRITORY,
except, in the case of SYNAGIS, pursuant to the terms of
that
6
certain Co-Promotion Agreement,
dated as of November 26, 1997, by and between MEDIMMUNE and
Abbott Laboratories (through its Ross Products Division), as
amended.
2.2
NON-DIVERSION AND
BUNDLING .
Notwithstanding the foregoing provisions of Section 2.1
, to the extent permitted by applicable law, ABBOTT agrees that
ABBOTT and its AFFILIATES will not sell any of the PRODUCTS to any
THIRD PARTY if ABBOTT (or its AFFILIATES) knows or has reason to
believe that the PRODUCT will be re-sold or exported outside of the
TERRITORY by such THIRD PARTY. If, after sale of the PRODUCT
to a THIRD PARTY, ABBOTT (or its AFFILIATES) learns or reasonably
suspects (based on information obtained from MEDIMMUNE or a THIRD
PARTY) that such PRODUCT was re-sold or exported outside of the
TERRITORY, ABBOTT agrees to provide prompt written notice to
MEDIMMUNE (except to the extent such information was initially
provided by MEDIMMUNE) and make (or cause its AFFILIATES to make)
reasonable efforts to obtain assurance from such THIRD PARTY that
it will not divert the sale of the PRODUCT outside the
TERRITORY. If such assurance cannot be timely obtained,
ABBOTT shall, if permitted under local laws, cease (or cause its
AFFILIATES to cease) further sales of all PRODUCTS to such THIRD
PARTY until reasonable assurance has been obtained from such THIRD
PARTY that it will cease its resale or export activities with
respect to such PRODUCT. ABBOTT agrees that, with respect to
its procedures related to limiting resale or export of the PRODUCTS
by THIRD PARTIES, in addition to the foregoing, ABBOTT will treat
the PRODUCTS similarly to other ABBOTT products. Furthermore,
the PARTIES agree that if, despite the foregoing, the resale or
export of the PRODUCTS by THIRD PARTIES results in significant
negative economic consequences to MEDIMMUNE, the PARTIES will meet
in good faith to negotiate an appropriate resolution to the
situation.
ABBOTT will not, without
MEDIMMUNE’S written consent, (a) discount the selling price
of any PRODUCT in order to promote the sales of other products of
ABBOTT, or (b) bundle the PRODUCTS for sale with any other products
(including other PRODUCTS). ABBOTT agrees that in all cases
it will conduct all price negotiations in good faith on an arms
length basis.
2.3
LABELING AND
PACKAGING .
ABBOTT shall prepare all labeling, packaging and package inserts
for PRODUCTS in conformity with regulatory guidelines in each
country of the TERRITORY, which labeling shall clearly indicate
that the PRODUCT is manufactured by or on behalf of MEDIMMUNE and
is being distributed by ABBOTT, to the extent that such statements
are allowed under the applicable laws and regulations in any
particular country of the TERRITORY.
ABBOTT shall submit the company core
datasheet (CCDS) and packaging to be used for PRODUCT in the MAJOR
MARKETS to MEDIMMUNE for approval, which approval shall not
unreasonably be withheld. If the proposed local labeling for a
country in a MAJOR MARKET: (a) is materially changed from the CCDS
previously approved by MEDIMMUNE pursuant to this
Section 2.3 , (b) is approved for such country more
than two (2) CONTRACT YEARS earlier, or (c) is reasonably requested
to be submitted for review by MEDIMMUNE (provided however that,
MEDIMMUNE may make such request to review no more than once
annually), ABBOTT shall submit such labeling to MEDIMMUNE for
approval, which approval shall not unreasonably be withheld. In all
cases, MEDIMMUNE shall be deemed to have approved such submitted
labeling, packaging or packaging inserts unless MEDIMMUNE provides
ABBOTT written
7
objection or approval thereto within
twenty (20) days after receipt thereof, but in no event later than
ten (10) days prior to any applicable regulatory deadline (assuming
timely notification by ABBOTT at least thirty (30) days before such
deadline).
2.4
SUBDISTRIBUTORS
. ABBOTT agrees not to sell
the PRODUCTS through subdistributors without the written consent of
MEDIMMUNE, which consent shall not be unreasonably withheld. If
such consent is granted, ABBOTT shall remain fully liable and
responsible to MEDIMMUNE for the activities of a subdistributor
appointed by ABBOTT and will monitor any subdistributors to ensure
that such subdistributors actions are not inconsistent with the
obligations of ABBOTT under this AGREEMENT.
2.5
RIGHT OF FIRST
OFFER . If at any time during the TERM, MEDIMMUNE
develops and has marketing rights to [***] ( “COMPETING
PRODUCT” ) and MEDIMMUNE desires to grant rights to
distribute a COMPETING PRODUCT in one or more countries of the
TERRITORY, then MEDIMMUNE shall first notify ABBOTT in writing that
it is seeking to appoint such a distributor and if, within thirty
(30) days after such written notice, ABBOTT notifies MEDIMMUNE in
writing that ABBOTT is interested in becoming that distributor,
then MEDIMMUNE and ABBOTT shall negotiate in good faith the terms
and conditions of a distribution agreement for such COMPETING
PRODUCT in such countries. If the PARTIES do not reach
agreement as to the terms and conditions of such a distribution
agreement within sixty (60) days after MEDIMMUNE receives such
written notice from ABBOTT or ABBOTT does not notify MEDIMMUNE in
writing of ABBOTT’s interest within the thirty (30) day
period after the written notice from MEDIMMUNE, then MEDIMMUNE may
grant such rights to a THIRD PARTY. Notwithstanding the
foregoing, in the event the PARTIES were unable to reach an
agreement as to the terms and conditions, MEDIMMUNE shall not offer
such appointment to a THIRD PARTY on terms and conditions
that are, on the whole, more favorable considering the economic
value of the transaction, without first offering such terms and
conditions to ABBOTT. Neither PARTY shall have the obligation
to enter into an agreement with respect to distribution of a
COMPETING PRODUCT and neither shall have liability for failing to
enter into any such agreement. Notwithstanding anything in
this Section 2.5 to the contrary, MEDIMMUNE may,
itself, distribute a COMPETING PRODUCT in the TERRITORY through
local wholesale distribution channels without first offering
distribution rights to ABBOTT under this Section 2.5 ,
provided that any THIRD PARTY appointed by MEDIMMUNE for such local
distribution shall not market or promote the PRODUCT in the
TERRITORY.
3.
PURCHASE OF
PRODUCTS
3.1
(a)
REQUIREMENTS
. Subject to the terms and
conditions of this AGREEMENT, during the TERM of this
AGREEMENT, MEDIMMUNE shall sell exclusively to ABBOTT and ABBOTT
shall purchase, exclusively from MEDIMMUNE, ABBOTT’s
requirements of each PRODUCT for sale in the TERRITORY.
ABBOTT shall pay the price for such PRODUCT as set forth in
Section 3.2 .
(b)
SUPPLY PLANNING
. Subject to the availability of
PRODUCT from MEDIMMUNE, ABBOTT shall maintain sufficient
inventories of PRODUCT to enable ABBOTT to effectively satisfy
demand for PRODUCT in the TERRITORY. Subject to
Section 3.6 , MEDIMMUNE shall use COMMERCIALLY
REASONABLE EFFORTS to establish and maintain a manufacturing
schedule and inventory on-hand of each PRODUCT sufficient
to
8
supply ABBOTT’s demands of
such PRODUCT, in 50 mg and 100 mg presentations (or any other
presentations that may be approved by the Manufacturing Steering
Committee) as set forth in the forecasts submitted by ABBOTT in
accordance with the terms of Section 5
hereof.
3.2
PRODUCT PRICE
. Certain definitions related
to this Section 3.2 are set forth in Exhibit 3.2
which is hereby incorporated by reference.
(a)
INVOICE/PAYMENT
. MEDIMMUNE shall invoice
ABBOTT for all PRODUCT delivered by MEDIMMUNE to the carrier and
ABBOTT shall pay MEDIMMUNE for such PRODUCT, all in accordance with
this Section 3.2 . The invoice amount shall be
denominated in U.S. Dollars. MEDIMMUNE shall forward all
invoices for PRODUCT ordered hereunder to a U.S. location as
designated by ABBOTT. The invoice submitted by MEDIMMUNE
shall include a statement of the royalties owed by MEDIMMUNE to
THIRD PARTIES on the PRODUCT for the purposes of determining the
BASE PRICE.
(b)
MINIMUM PRICE/INVOICE
PRICE . No
earlier than delivery of PRODUCT to the carrier, MEDIMMUNE shall
invoice ABBOTT at the MINIMUM PRICE for such PRODUCT multiplied
by the number of UNITS of PRODUCT delivered to the carrier, and
ABBOTT shall pay MEDIMMUNE the total amount shown on such invoice
(the “INVOICE PRICE”) within forty-five (45) days after
the date of invoice. The MINIMUM PRICE shall be
non-refundable.
(c)
FINAL PRICE
. Within forty-five (45) days
after the end of each CALENDAR QUARTER, ABBOTT shall pay MEDIMMUNE
(without the need for any further invoice) the difference between
(i) the aggregate FINAL PRICE and (ii) the aggregate INVOICE PRICE
for all UNITS of PRODUCT sold by ABBOTT during such CALENDAR
QUARTER plus the aggregate amount, if any, paid by ABBOTT
for FIRST SEASON PRE-APPROVAL PRODUCT in connection with REGULATORY
APPROVAL and in accordance with Section 3.2(e) .
For any CALENDAR QUARTER, if the aggregate INVOICE PRICE for all
PRODUCT sold by ABBOTT during that CALENDAR QUARTER (as determined
by specific identification) plus the aggregate amount, if
any, paid by ABBOTT for FIRST SEASON PRE-APPROVAL PRODUCT in
connection with REGULATORY APPROVAL and in accordance with
Section 3.2(e) is greater than the aggregate FINAL
PRICE for all PRODUCT sold by ABBOTT during that CALENDAR QUARTER,
then ABBOTT shall forfeit the excess amount paid. This
determination will be conducted with specific identification of and
separate calculation of each inventory layer and each UNIT
type. For clarity, the calculation of FINAL PRICE will not
include SAMPLES (i.e., ABBOTT shall only be obligated to pay the
INVOICE PRICE for such SAMPLES).
(d)
EXPIRED, UNSOLD
PRODUCT . On
December 15 of each CONTRACT YEAR and within forty-five (45)
days of the last day of the TERM, ABBOTT shall pay MEDIMMUNE
(without the need of any further invoice), the difference between
the FINAL PRICE and the INVOICE PRICE for all UNITS of PRODUCT not
sold by ABBOTT that expired during the period between
October 1 of the previous CONTRACT YEAR and September 30
of the subject CONTRACT YEAR (or the last day of the TERM in the
case of the last CONTRACT YEAR), other than FIRST SEASON
PRE-APPROVAL
9
PRODUCT. If the INVOICE PRICE
is greater than the FINAL PRICE, then ABBOTT shall forfeit the
excess amount paid. This payment shall include a report with
respect to the expired vials for the applicable period.
(e)
FIRST SEASON PRE-APPROVAL
PRODUCT .
Within thirty (30) days after receipt of REGULATORY APPROVAL in any
country in the MAJOR MARKETS, for all FIRST SEASON PRE-APPROVAL
PRODUCT that has not expired and has a remaining shelf life as of
the time of REGULATORY APPROVAL of [***] or greater, ABBOTT shall
pay MEDIMMUNE the difference between (a) the INVOICE PRICE ABBOTT
would have been obligated to pay to MEDIMMUNE had such PRODUCT
initially not been designated FIRST SEASON PRE-APPROVAL PRODUCT and
(b) the INVOICE PRICE initially paid by ABBOTT for such
PRODUCT. The additional payment together with the initial
payment shall be deemed to be the aggregate nonrefundable minimum
price for the applicable PRODUCT. With respect to FIRST
SEASON PRE-APPROVAL PRODUCT that has a remaining shelf life as of
the time of REGULATORY APPROVAL of less than [***], ABBOTT shall
have no payment obligation upon receipt of REGULATORY APPROVAL, but
if such PRODUCT is sold by ABBOTT, then ABBOTT shall pay MEDIMMUNE
the FINAL PRICE less the INVOICE PRICE for such PRODUCT in the
CALENDAR QUARTER in which it is sold in accordance with
Section 3.2(c) . With respect to FIRST SEASON
PRE-APPROVAL PRODUCT that, as of the time of REGULATORY
APPROVAL, has expired or has a remaining shelf life of less
than [***] and is not subsequently sold by ABBOTT, ABBOTT shall
have no payment obligations to MEDIMMUNE other than the INVOICE
PRICE paid for such PRODUCT in accordance with
Section 3.2(b) .
(f)
FOREIGN EXCHANGE
CALCULATION .
Whenever conversion from any currency into U.S. Dollars shall be
required under this AGREEMENT (e.g., for the determination of NET
SALES), such conversion shall be completed for each month of the
CALENDAR QUARTER as follows: the value to be converted shall
be calculated with respect to each country in local currency and
then converted into U.S. dollars based on the average rate of
exchange for that month (based on daily noon buying rates for cable
transfers in New York City certified for customs purposes by the
Federal Reserve Bank of New York, available on the website for the
Board of Governors of the Federal Reserve System (or any successor
entity)). In connection with its payment obligations each
CALENDAR QUARTER, ABBOTT will provide electronically to MEDIMMUNE a
detailed reconciliation, in form and substance reasonably
acceptable to MEDIMMUNE, showing the rates used, confirming the
source of the rates used and the conversion
calculations.
(g)
NET SALES
DOCUMENTATION .
With each quarterly payment, ABBOTT shall deliver to
MEDIMMUNE a full and accurate accounting to include at least the
following information:
(i)
Quantity of each PRODUCT sold and/or
withdrawn by transaction type (by country, by month) by ABBOTT and
its AFFILIATES.
10
(ii)
Total amount invoiced for each
PRODUCT (by country, by month) in local currency.
(iii)
Calculation of NET SALES (by
country, by month) in local currency for each PRODUCT.
(iv)
Exchange rates for converting each
local currency into U.S. Dollars showing the source conversion
rates used in accordance with Section 3.2(f) for each
month of the CALENDAR QUARTER.
(v)
NET SALES in U.S. dollars in each
country for each PRODUCT.
(vi)
Total compensation payable to
MEDIMMUNE; or to be credited to ABBOTT in accordance with
Section 3.2(e) .
(h)
INVENTORY RECONCILIATION
REPORT . Within
forty-five (45) days following the end of each CONTRACT YEAR,
ABBOTT shall provide MEDIMMUNE an inventory reconciliation for such
CONTRACT YEAR.
(i)
ABBOTT BOOKS AND
RECORDS .
ABBOTT shall keep, and shall cause each of its AFFILIATES to keep
full and accurate books of account containing all particulars that
may be necessary for the purpose of calculating all payments
payable to MEDIMMUNE. Such books of account shall be kept at their
principal place of business and, with all necessary supporting data
shall, for the next two (2) years following the end of the calendar
year to which each shall pertain be open for inspection by an
independent certified accountant selected by MEDIMMUNE and
reasonably acceptable to ABBOTT upon reasonable notice during
normal business hours, at MEDIMMUNE’s expense, for the sole
purpose of verifying payments or compliance with this AGREEMENT,
but in no event more than once in each calendar year. All
information and data offered shall be used only for the purpose of
verifying payments. The independent certified public
accountant performing any such audit shall not disclose to
MEDIMMUNE or to any other Person any confidential information of
ABBOTT or any of its AFFILIATES. The independent certified
public accountant shall report to MEDIMMUNE only the results of
such audit and only such underlying facts as is necessary to
explain the results of such audit. In the event that such
inspection shall indicate that in any CONTRACT YEAR that the
payments which should have been paid by ABBOTT are at least five
percent (5%) greater than those which were actually paid by ABBOTT,
then ABBOTT shall pay the cost of such inspection. All
underpayments are immediately due and payable.
(j)
PRODUCT
EXPIRATION .
All expired PRODUCT in ABBOTT’s possession shall be
immediately destroyed by ABBOTT, at ABBOTT’s expense, and
evidence of such destruction shall be sent to MEDIMMUNE.
(k)
REPORTS
. Within forty-five (45) days
following the end of each CALENDAR QUARTER, as part of the report
under Section 3.2(c) , ABBOTT shall provide to
MEDIMMUNE a written country-by-country and PRODUCT-by-PRODUCT
report of the inventory and sales of each PRODUCT during each month
of such CALENDAR QUARTER.
11
(l)
MEDIMMUNE BOOKS AND
RECORDS .
MEDIMMUNE shall keep, and shall cause each of its AFFILIATES to
keep full and accurate books of account containing all particulars
that may be necessary for the purpose of calculating all THIRD
PARTY royalties on the PRODUCT owing and/or paid by MEDIMMUNE and
the calculation of the COST OF GOODS. Such books of account
shall be kept at their principal place of business and, with all
necessary supporting data shall, for the next two (2) years
following the end of the calendar year to which each shall pertain
be open for inspection by an independent certified public
accountant selected by ABBOTT and reasonably acceptable to
MEDIMMUNE upon verifying such royalties or compliance with this
AGREEMENT, but in no event more than once in each calendar
year. All information and data offered shall be used only for
such purpose. The independent certified public accountant
performing any such audit shall not disclose to ABBOTT or to any
other Person any confidential information of MEDIMMUNE or any of
its AFFILIATES. The independent certified public accountant
shall report to ABBOTT only the results of such audit and only such
underlying facts as is necessary to explain the results of such
audit. In the event that such inspection shall indicate that
in any CONTRACT YEAR, the THIRD PARTY royalties reported as owed
and/or paid by MEDIMMUNE or the calculation of the COST OF
GOODS are at least five percent (5%) greater than those which were
actually owed and/or paid by MEDIMMUNE, then MEDIMMUNE shall pay
the cost of such inspection. All amounts reported as owed
and/or paid for THIRD PARTY royalties which are in excess of the
amounts actually owed and/or paid by MEDIMMUNE on the PRODUCT shall
immediately be credited against any and all amounts due and owing
by ABBOTT to MEDIMMUNE under this AGREEMENT.
3.3
[Reserved.]
3.4
REVERSION EVENT
.
(a)
REVERSION EVENT
. A REVERSION EVENT will be
deemed to have occurred if:
(i)
MEDIMMUNE is required by a
REGULATORY AUTHORITY in any country in the MAJOR MARKETS to
discontinue due to a safety concern or other reason beyond the
control of MEDIMMUNE, the development of NUMAX prior to obtaining
REGULATORY APPROVAL for NUMAX in such country; provided ,
however , that, a suspension of development activities for
the purpose of redesigning the protocols in response to a
regulatory request or action shall not be considered a
discontinuation of development for purposes of this
subsection;
(ii)
the PARTIES mutually agree in
writing that the development of NUMAX should be discontinued prior
to the filing for REGULATORY APPROVAL of NUMAX in any country in
the MAJOR MARKET due to material adverse deviations from the
anticipated safety profile for NUMAX that arise or become known to
either PARTY after the EFFECTIVE DATE;
12
(iii)
[***]: (A) NUMAX has not received
REGULATORY APPROVAL in at least [***] of the MAJOR MARKETS, and (B)
all pivotal clinical trials for NUMAX in all countries of the MAJOR
MARKETS, including but not limited to the PHASE III CLINICAL TRIAL,
have been terminated;
(iv)
the PHASE III CLINICAL TRIAL is
stopped voluntarily by MEDIMMUNE; provided, however, that, a
suspension of the PHASE III CLINICAL TRIAL for the purpose of
redesigning the protocols in response to a regulatory request or
action shall not be considered a stoppage of the PHASE III CLINICAL
TRIAL for purposes of this subsection;
(v)
the PHASE III CLINICAL TRIAL is (A)
permanently discontinued or (B) suspended and reasonably estimated
to be delayed for more than [***] from the date of suspension as a
result of action or inaction by a THIRD PARTY or by MEDIMMUNE, in
either case as a result of gross negligence or willful misconduct
by MEDIMMUNE in the execution of (but not the design, analysis,
interpretation or any other aspect of) the PHASE III CLINICAL TRIAL
(e.g., for failure to pay the necessary clinical research
organization(s) to complete the trial).
Notwithstanding the foregoing, in
the event that the PHASE III CLINICAL TRIAL is ongoing on or after
[***] and NUMAX has not been approved in at least [***] of the
MAJOR MARKETS, then at any time after [***], subject to the
limitation in Section 3.4(b) , ABBOTT shall have the
sole discretion to declare a REVERSION EVENT upon ninety (90) days
written notice to MEDIMMUNE.
With respect to
Section 3.2(a)(v) above, a REVERSION EVENT shall only
be deemed to have occurred upon a finding of gross negligence or
willful misconduct by a court of competent jurisdiction (or in
accordance with the alternate dispute resolution mechanism set
forth provided for in Section 15.7 ). If, as a
result, a REVERSION EVENT has been deemed to have occurred and
MEDIMMUNE cures the cause of the discontinuation or delay within
one (1) year following the occurrence of such REVERSION EVENT, then
no later than forty-five (45) days after any notice of cure, ABBOTT
shall have the right, in its sole discretion and with written
notice to MEDIMMUNE, to declare that a REVERSION EVENT did not take
place, in which case ABBOTT’s rights to NUMAX shall be
reinstated as if such REVERSION EVENT had not occurred and the
FINAL PRICE from that point forward shall also be calculated as if
a REVERSION EVENT had not occurred. In addition, no later
than thirty (30) days after the reinstatement of ABBOTT’s
rights hereunder, ABBOTT shall pay MEDIMMUNE [***] of the total
amount of any excess of the FINAL PRICE that would have been paid
if the REVERSION EVENT had not occurred over the total amount of
the FINAL PRICE that was actually paid during the period that such
REVERSION EVENT existed.
(b)
LIMITATION ON REVERSION
EVENT .
Notwithstanding anything Section 3.4(a) to the
contrary, if, upon receipt of REGULATORY APPROVAL in [***] of the
MAJOR MARKETS a REVERSION EVENT has not previously occurred or been
declared, then for the remainder of the TERM this
Section 3.4 shall be
13
deemed null and void (i.e., there
shall not be a REVERSION EVENT at any time thereafter).
3.5
REASONABLE EFFORTS TO
SUPPLY .
Subject to this Section 3.5 and Section 5.2
, MEDIMMUNE agrees to use its COMMERCIALLY REASONABLE EFFORTS to
supply ABBOTT with ABBOTT’s requirements of each of the
PRODUCTS for sale to customers in the TERRITORY. Following
the LAUNCH of NUMAX in any country in the TERRITORY, MEDIMMUNE
shall continue to supply SYNAGIS to ABBOTT for sale in all
countries in the TERRITORY in which the relevant REGULATORY
AUTHORITIES have refused to permit ABBOTT to remove SYNAGIS from
the market or in which the transition of the market from SYNAGIS to
NUMAX has not, in ABBOTT’s determination after consultation
with the Manufacturing Steering Committee, been completed.
ABBOTT shall use COMMERCIALLY REASONABLE EFFORTS to discontinue
older PRODUCTS or formulations of PRODUCTS (including, but not
limited to, the lyophilized formulation of SYNAGIS) or to
transition from one PRODUCT to another as such new formulations or
PRODUCTS are made available by MEDIMMUNE per the direction of the
Manufacturing Steering Committee.
3.6
SHORTAGE AND
ALLOCATION .
MEDIMMUNE’s obligation to supply PRODUCT under
Section 3.1 hereof shall at all times be subject to the
condition that MEDIMMUNE is able to obtain or make a sufficient
supply of such PRODUCT for sale both inside and outside of the
TERRITORY. In the event that PRODUCT available to MEDIMMUNE is in
short supply, MEDIMMUNE shall notify ABBOTT of such shortage as
soon as possible. In the event there is a short supply of PRODUCT
and MEDIMMUNE cannot supply PRODUCT to ABBOTT in an amount equal to
ABBOTT’s FIRM ORDER, then MEDIMMUNE shall allocate available
PRODUCT to ABBOTT in each month that such a shortfall exists (and
in each month thereafter until the shortfall to ABBOTT is remedied)
in an amount equal to the product of (a) the amount of available
PRODUCT for that month and (b) a fraction the numerator of which is
(1) the aggregate quantity of FIRM ORDERS made by ABBOTT over the
subsequent [***] period including the shortfall month and the
denominator of which is (2) the sum of (x) the aggregate quantity
of FIRM ORDERS made by ABBOTT over the subsequent [***] period
including the shortfall months and (y) the aggregate quantity of
PRODUCT over the same [***] period required by MEDIMMUNE outside
the TERRITORY by reference to FIRM ORDERS placed with THIRD PARTY
MANUFACTURERS for MEDIMMUNE’s requirements and the amount to
be produced at a MEDIMMUNE facility for MEDIMMUNE’s
requirements, in each case outside the TERRITORY.
Notwithstanding the foregoing, provided that ABBOTT has previously
requested or consented in writing to the discontinuation of a
PRODUCT in one or more countries of the TERRITORY, MEDIMMUNE will
not be required to provide such PRODUCT in such countries for the
remainder of the TERM.
3.7
[Reserved.]
3.8
MINIMUM SALE
THRESHHOLD .
Notwithstanding anything to the contrary herein, in the event that
the NET SALES of all PRODUCTS in the TERRITORY fails to exceed
[***] in any CONTRACT YEAR, unless ABBOTT pays to MEDIMMUNE, within
thirty (30) days following the end of the CONTRACT YEAR, [***] of
the difference between [***] and the NET SALES achieved by ABBOTT,
MEDIMMUNE may, at its sole discretion, convert the exclusive rights
granted herein to non-exclusive rights in the TERRITORY.
14
The PARTIES agree that the [***]
minimum sales threshold referenced in the preceding paragraph will
be reduced as follows in the event that ABBOTT’s rights to a
PRODUCT in one or more countries are terminated pursuant to
Section 14.3 :
(a)
if ABBOTT terminates its right to
Canada, the minimum sales threshold will be reduced by
[***];
(b)
if ABBOTT terminates its right to
all of the countries of the European Union, the minimum sales
threshold will be reduced by [***]; and
(c)
if ABBOTT terminates its right to
Japan, the minimum sales threshold will be reduced by
[***].
(b)
ABBOTT shall be excused from its
minimum sales obligations under this Section 3.8 with
respect to any CONTRACT YEAR in which the failure to meet such
minimum sales requirement is related to: (i) a failure by MEDIMMUNE
to fill ABBOTT’s FIRM ORDERS during such CONTRACT YEAR, (ii)
MEDIMMUNE’s failure to promptly replace material quantities
of defective or non-conforming PRODUCT, or (iii) as a result of a
THIRD PARTY selling a product in the TERRITORY which infringes a
granted patent in the TERRITORY which is based on Patent
Cooperation Treaty Application [***] and the net sales of the
infringing THIRD PARTY product is [***] of ABBOTT’s NET SALES
of PRODUCT in the TERRITORY in the applicable CONTRACT YEAR;
provided, however that, if ABBOTT’s failure to meet such
obligations is not wholly due to a cause set forth in subsections
(i), (ii) or (iii) above, then applicable minimum sales obligation
threshold will be prorated to the extent such cause impaired
ABBOTT’s ability to meet its obligations.
4.
DELIVERY, PAYMENT AND RISK OF
LOSS
4.1
(a)
CURRENCY
. All payments under this
AGREEMENT shall be remitted in immediately available funds. Unless
otherwise agreed between the PARTIES all payments shall be in U.S.
Dollars.
(b)
LATE FEES
. In the event that any
payment due hereunder is not made when due, the payment shall
accrue interest beginning on the first day of the month following
the date when such payment was due, calculated at the annual rate
of the sum of (i) two percent (2%) plus (ii) the prime interest
rate quoted by Citibank, N.A., New York, New York, on the date such
payment is due, or on the date payment is made, whichever is
higher, the interest being compounded on the last day of each
calendar month; provided that in no event shall said annual rate
exceed the maximum legal interest rate for corporations. Such
payment when made shall be accompanied by all interest
accrued. Said interest and the payment and acceptance thereof
shall not negate or waive the right of MEDIMMUNE to any other
remedy, legal or equitable, to which MEDIMMUNE may be entitled
because of the delinquency of the payment.
4.2
TITLE AND RISK OF
LOSS . Title to
PRODUCT sold hereunder, and risk of loss with respect to such
PRODUCT, shall pass to ABBOTT upon delivery of the PRODUCT to a
carrier designated by ABBOTT at the place at which the PRODUCT is
manufactured or
15
stored. Upon the passage of title,
MEDIMMUNE’s liability with respect to risk of loss shall
cease, and ABBOTT shall be the owner of such PRODUCT for all
purposes, including, without limitation, the marketing, sale and
setting of prices for the PRODUCT sold by ABBOTT to its
customers. ABBOTT shall, in writing, provide MEDIMMUNE with
instructions regarding the delivery destination for each
order of the PRODUCT and MEDIMMUNE shall arrange the shipment of
each order in accordance with such instructions. ABBOTT shall be
responsible for the cost of freight and insurance with respect to
each shipment of the PRODUCTS.
4.3
CONFLICTING
TERMS . No
provision on ABBOTT’s purchase order forms which may purport
to impose different conditions upon the parties hereto shall modify
the terms of this AGREEMENT.
5.
FORECASTS AND
ORDERS
5.1
(a)
FORECASTS
. ABBOTT shall provide
MEDIMMUNE, on or before the tenth day of the last month of each
CALENDAR QUARTER, with a three-year product forecast planning
horizon for each PRODUCT. The rolling forecasts are to
be broken down to single months and shall include the anticipated
quantity of PRODUCT in terms of the formulation and presentation of
each PRODUCT. The forecasts for each PRODUCT within the first year
(months 1 through 12) are FIRM ORDERS and cannot be changed and the
forecasts for the second year (month 13 through 24) are partly
binding forecasts which means that the forecasts can be changed
within this period. The forecasts can be increased in consultation
with the Manufacturing Steering Committee, but are limited to the
following restrictions when decreased:
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[***]
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[***]
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[***]
|
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[***]
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[***]
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[***]
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[***]
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[***]
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The forecast for the third year
(months 25-36) is a non-binding forecast.
Notwithstanding the foregoing, in
the event that MEDIMMUNE assumes the manufacture of any PRODUCT
that is, as of the EFFECTIVE DATE, manufactured by a THIRD PARTY
MANUFACTURER, the PARTIES shall discuss, in good faith, an
adjustment to the forecast reductions that ABBOTT will be
permitted. If the PARTIES cannot come to an agreement
regarding any such adjustment, the forecast reductions shall remain
as set forth above.
Notwithstanding the foregoing,
MEDIMMUNE shall use its COMMERCIALLY REASONABLE EFFORTS to comply
with unplanned changes in FIRM ORDERS, but shall not be held liable
for its inability to do so. In each FIRM ORDER for any month,
ABBOTT shall state, after consultation with MEDIMMUNE, a reasonable
delivery schedule for PRODUCTS to be delivered in that
month.
Notwithstanding anything to the
contrary in this Section 5.1(a), MEDIMMUNE reserves the right
to spread the supply of PRODUCT throughout the
16
CONTRACT YEAR, provided that if the
supply does not meet the specified order dates, then the supply
shall be reasonably related to ABBOTT’s demand requirements
for the PRODUCTS at the time of delivery in such CONTRACT
YEAR.
(b)
NUDE VIALS
. All PRODUCT shall be
supplied to ABBOTT by MEDIMMUNE and shall be ordered by ABBOTT
based on UNIT type; without labeling, packaging and packaging
inserts. ABBOTT shall be responsible for the labeling, packaging
and packaging inserts of PRODUCT at ABBOTT’s sole cost and
expense (subject to MEDIMMUNE’s approval right set forth in
Section 2.3 ).
(c)
MINIMUM ORDER
QUANTITY . Except as otherwise provided in
Section 5.2 below, forecasts and order totals for each
CONTRACT YEAR shall be a minimum of [***] 100mg equivalent vials
for any one formulation of PRODUCT (e.g., lyophilized SYNAGIS, the
liquid formulation of SYNAGIS or NUMAX) (“Minimum Order
Quantity”). Notwithstanding the foregoing, during the
period of conversion of the market to the liquid formulation of
SYNAGIS or to NUMAX, ABBOTT shall, upon prior approval of the
Manufacturing Steering Committee, be entitled to order less than
the Minimum Order Quantity. In any CONTRACT YEAR of
conversion described above, in the event that ABBOTT does not order
the Minimum Order Quantity and has not obtained Manufacturing
Steering Committee approval, then ABBOTT shall pay MEDIMMUNE an
amount equal to the COST OF GOODS (plus royalties, if any, due by
MEDIMMUNE to any THIRD PARTIES on such COST OF GOODS) multiplied
by the amount by which the number of UNITS ordered by ABBOTT in
any CONTRACT YEAR is less than the Minimum Order Quantity (such
amount, the “Deficiency”). For the sake of
clarity, in the event the Manufacturing Steering Committee has
approved the ordering of less than the Minimum Order Quantity,
ABBOTT shall not be liable to pay the Deficiency. ABBOTT
shall pay MEDIMMUNE any amount due hereunder no later than thirty
(30) days after the end of the applicable CONTRACT YEAR.
5.2
SUPPLY
HARMONIZATION . ABBOTT and MEDIMMUNE shall jointly
create a steering committee (“Manufacturing Steering
Committee”) to coordinate: (a) the material management/supply
chain logistics related to the partial or complete conversion of
one formulation of a PRODUCT to another (including, but not limited
to, the conversion from the lyophilized formulation of SYNAGIS to
the liquid formulation of SYNAGIS), (b) the manufacture and
distribution of the PRODUCTS in the event of the introduction of
any PRODUCT or formulation of the PRODUCT in the TERRITORY
(including any related REGULATORY FILINGS or communications related
to REGULATORY APPROVAL thereof, but in each such case only to the
extent specifically related to the manufacture or distribution of
the PRODUCTS), (c) the development and management of change control
processes for any PRODUCT, (d) the development of an inventory
management process for any PRODUCT, (e) participation in THIRD
PARTY MANUFACTURER interactions, and (f) any adjustment of the
minimum order quantities set forth in Section 5.1(c) above, as
necessary to facilitate any launch of NUMAX or of the liquid
formulation of SYNAGIS and to minimize the amount of expired
PRODUCT. The Manufacturing Steering Committee shall develop
and implement plans for the initial introduction of the PRODUCT or
conversion of any formulation of the PRODUCT with the goal of
minimizing the amount of expired PRODUCT or formulation upon
conversion. Except as otherwise provided under
Section 7.7(b) , a deadlock with respect
17
to any decision to be reached by the
Manufacturing Steering Committee shall be resolved by MEDIMMUNE;
provided , however , that (i) the Manufacturing
Steering Committee may not wholly discontinue the production of
either SYNAGIS or NUMAX or an approved presentation (e.g., 50mg
vials and 100mg vials) without ABBOTT’s consent, and (ii)
ABBOTT shall have the final decision making authority with respect
to the management of the inventory of PRODUCT and ordering of
PRODUCT consistent with Section 5.1 . The PARTIES
shall use COMMERCIALLY REASONABLE EFFORTS to convene the first
Manufacturing Steering Committee meeting within forty-five (45)
days after the EFFECTIVE DATE and, thereafter the Manufacturing
Steering Committee shall convene as frequently as necessary, but
not less than once every CALENDAR QUARTER.
6.
REGULATORY AND CLINICAL
DEVELOPMENT ISSUES
6.1
REGULATORY FILINGS AND
FEES . ABBOTT
shall use COMMERCIALLY REASONABLE EFFORTS to obtain REGULATORY
APPROVAL for NUMAX in all countries in the TERRITORY in which, in
ABBOTT’s reasonable determination, the market potential of
NUMAX in such country warrants seeking such REGULATORY APPROVAL,
but at least in all countries in the MAJOR MARKETS, and to seek the
most favorable reimbursement rates for NUMAX in such countries
(consistent with applicable law). MEDIMMUNE shall provide
ABBOTT with any support and documentation reasonably requested by
ABBOTT to make such REGULATORY FILINGS. ABBOTT shall be
solely responsible for the preparation, filing, presentation and
maintenance of all REGULATORY FILINGS and, subject to the
satisfaction by MEDIMMUNE of its obligations under this AGREEMENT,
for obtaining all REGULATORY APPROVALS for the PRODUCTS. All
REGULATORY APPROVALS for NUMAX shall be owned by and held by ABBOTT
or its AFFILIATES. Except as otherwise specifically provided
under Sections 7.7 and 7.8 , ABBOTT shall be
responsible for all filing, user and other administrative fees
associated with: (a) the submission of REGULATORY FILINGS for
PRODUCT in the TERRITORY, and (b) for obtaining and maintaining the
REGULATORY APPROVALS for each PRODUCT in the TERRITORY.
ABBOTT shall exercise COMMERCIALLY REASONABLE EFFORTS to maintain
REGULATORY APPROVAL, pricing approval and reimbursement
approval for each PRODUCT in each country of the TERRITORY in which
REGULATORY APPROVAL is obtained. Notwithstanding anything in
the foregoing to the contrary, if the REGULATORY AUTHORITIES in any
country in the TERRITORY require one or more additional
post-approval studies (other than studies related to Discretionary
Changes or Required Changes (which are addressed in
Section 7.7 )) (“POST-APPROVAL STUDIES”) to
obtain or maintain REGULATORY APPROVAL, and ABBOTT reasonably
determines that the cost of conducting such POST-APPROVAL STUDIES
is not commercially feasible in light of the size and potential of
the market for the PRODUCT in such country, MEDIMMUNE may, but
shall not be required to, conduct such required POST-APPROVAL
STUDIES. Upon completion of such POST-APPROVAL STUDIES by
MEDIMMUNE, ABBOTT shall be entitled to assume the responsibility of
obtaining REGULATORY APPROVAL in such country provided that the
PARTIES are able to successfully negotiate the commercial terms by
which MEDIMMUNE will be compensated for the actual costs incurred
by MEDIMMUNE in connection with the POST-APPROVAL STUDIES conducted
by MEDIMMUNE. In the event that the PARTIES are unable to
negotiate the terms of compensation to MEDIMMUNE for the
POST-APPROVAL STUDIES, ABBOTT’s rights to such PRODUCT in
such country shall be forfeited. For the sake of
18
clarity, a forfeiture of
ABBOTT’s rights pursuant to the preceding sentence, shall not
be a considered a REVERSION EVENT for purposes of
Section 3.4 .
6.2
[Reserved.]
6.3
COMMUNICATION WITH REGULATORY
AUTHORITIES .
Except as otherwise specifically provided herein, ABBOTT shall have
sole responsibility for communicating with the REGULATORY
AUTHORITIES in the TERRITORY regarding all regulatory matters with
respect to the PRODUCTS and MEDIMMUNE shall have sole
responsibility for communicating with any REGULATORY AUTHORITIES
outside the TERRITORY with respect to the PRODUCTS. ABBOTT
acknowledges that prior to the EFFECTIVE DATE, MEDIMMUNE has had
communications with REGULATORY AUTHORITIES in the TERRITORY
regarding NUMAX. Accordingly, the PARTIES agree to work
cooperatively to transition responsibility to make REGULATORY
FILINGS to ABBOTT.
Each PARTY shall provide the other
PARTY with an opportunity, in advance of any REGULATORY FILING to,
or material communications with, any REGULATORY AUTHORITY in the
MAJOR MARKETS or the United States to review and comment on all
REGULATORY FILINGS or communications (including written responses
to any REGULATORY AUTHORITY questions) regarding the PRODUCTS,
including, but not limited to any such REGULATORY FILINGS or
communications related to the design or conduct of a clinical trial
for the PRODUCTS. Notwithstanding the foregoing, the filing
PARTY shall, in its sole discretion, determine the timing, manner
and content of any submission to or communication with any
REGULATORY AUTHORITY. Each PARTY shall provide the other
PARTY with copies of all material written communications between
the PARTY and REGULATORY AUTHORITIES in the MAJOR MARKETS or the
United States and any adverse finding or communication, oral or
written, by any such REGULATORY AUTHORITIES regarding the
PRODUCTS.
6.4
MEETINGS WITH REGULATORY
AUTHORITIES .
Each PARTY shall notify the other PARTY regarding upcoming meetings
between the PARTY and REGULATORY AUTHORITIES at which a matter
material to obtaining or maintaining REGULATORY APPROVAL of the
PRODUCT in the MAJOR MARKETS or the United States (including, but
not limited to related to the design or conduct of a clinical trial
from which data is expected to be used towards REGULATORY APPROVAL
for such PRODUCT) in the jurisdiction governed by such REGULATORY
AUTHORITY is expected to be discussed. No later than thirty
(30) days prior to any meeting with any REGULATORY AUTHORITIES in
the MAJOR MARKETS or the United States, the PARTIES shall convene
to discuss the matter(s) to be addressed at such meeting. To
the extent permissible, the non-filing PARTY shall have the right
to participate, at its own expense, in any such meeting between the
PARTY and the REGULATORY AUTHORITIES. Each PARTY agrees that
the non-filing PARTY’s presence at such meeting shall be, at
the discretion of the filing PARTY, in an observational capacity
only. The filing PARTY shall have the sole discretion
regarding all presentations, discussions and statements made and
strategies employed at any meeting with REGULATORY
AUTHORITIES. Each PARTY’s obligation to provide
information under this Section 6.4 , shall be limited
to providing such information as could reasonably be expected to
affect the other PARTY’s REGULATORY FILINGS.
19
6.5
CLINICAL AND REGULATORY
INFORMATION .
(a)
BY MEDIMMUNE
. To the extent not provided
to ABBOTT prior to the EFFECTIVE DATE and to the extent MEDIMMUNE
develops or has developed any data or information consistent with
the terms of this AGREEMENT that was not initially provided to
MEDIMMUNE by ABBOTT, MEDIMMUNE shall, as soon as practical
after the EFFECTIVE DATE and on a periodic basis, provide ABBOTT
with data and information that MEDIMMUNE has in its possession with
respect to NUMAX and the liquid formulation of SYNAGIS that is
necessary for ABBOTT to obtain appropriate REGULATORY APPROVALS in
the TERRITORY, which data and information may include, but would
not be limited to, filings with the FDA to the extent such
information could reasonably be expected to affect ABBOTT’s
REGULATORY FILINGS in the TERRITORY. Notwithstanding the
foregoing, primary source data will only be made available upon
request from the REGULATORY AUTHORITY where required for REGULATORY
APPROVAL. All such information provided by MEDIMMUNE shall be
in the English language. MEDIMMUNE and ABBOTT shall, through
the DEVELOPMENT COMMITTEE, jointly coordinate the best regulatory
approach and filing strategy necessary to assure the successful
submission and approval of NUMAX and the liquid formulation of
SYNAGIS in the TERRITORY. MEDIMMUNE shall provide ABBOTT
reasonable technical assistance and cooperation in connection with
ABBOTT’s efforts in obtaining and maintaining REGULATORY
APPROVAL of NUMAX and the liquid formulation of SYNAGIS in each
MAJOR MARKET. MEDIMMUNE shall provide ABBOTT access to
MEDIMMUNE’s clinical database and master SAS database upon
reasonable notice solely to enable ABBOTT to expediently respond to
queries from REGULATORY AUTHORITIES in the TERRITORY regarding the
PRODUCTS, including but not limited to, data regarding the Phase
III pivotal clinical trials for SYNAGIS; provided ,
however , that any response to such queries shall be first
submitted to MEDIMMUNE for review and comment. Any analysis,
reports and other materials prepared from the information provided
under this Section 5.5 , will be made available to
MEDIMMUNE consistent with Section 7.1 and other
applicable provisions of this AGREEMENT. Such analysis,
reports and other materials shall be used for the sole purpose of
obtaining REGULATORY APPROVAL or for any other purpose approved by
the DEVELOPMENT COMMITTEE.
(b)
BY ABBOTT
. To the extent not provided
to MEDIMMUNE prior to the EFFECTIVE DATE and to the extent ABBOTT
develops or has developed any data or information consistent with
the terms of this AGREEMENT that was not initially provided to
ABBOTT by MEDIMMUNE, ABBOTT shall, as soon as practical after the
EFFECTIVE DATE and on a periodic basis, provide MEDIMMUNE with data
and information that ABBOTT has in its possession with respect to
NUMAX and the liquid formulation of SYNAGIS that is necessary for
MEDIMMUNE to obtain appropriate REGULATORY APPROVALS outside the
TERRITORY, which data and information may include, but would not be
limited to, filings with the REGULATORY AUTHORITIES in the MAJOR
MARKETS to the extent such information could reasonably be expected
to affect MEDIMMUNE’s REGULATORY FILINGS outside the
TERRITORY. Notwithstanding the foregoing, primary source data
will only be mad
