Exhibit 10.41
AGREEMENT
BETWEEN
CONNETICS CORPORATION
AND
XXXXXXXX-XX XXXXX INC.
SALE AND PURCHASE AGREEMENT
This Sale and Purchase Agreement made as of the 2nd day of February, 2004
by and between Connetics Corporation, a corporation organized and existing under
the laws of the State of Delaware, having offices at 0000 X. Xxxxxxxx Xxxx, Xxxx
Xxxx, Xxxxxxxxxx 00000 ("Connetics") and Xxxxxxxx-Xx Xxxxx Inc., a corporation
organized and existing under the laws of the State of New Jersey, having offices
at 000 Xxxxxxxxx Xxxxxx, Xxxxxx, Xxx Xxxxxx 00000 ("Roche").
WHEREAS, Roche has marketed a pharmaceutical product under the trademark
Soriatane(R) that contains acitretin as its active ingredient;
WHEREAS, Roche has developed know-how and owns rights to
Soriatane(R)-brand acitretin;
WHEREAS, Roche and Connetics have entered into a non-disclosure agreement,
dated December 12, 2003 ("Non-Disclosure Agreement") under which Roche and
Connetics shared information with regard to the development, manufacture and
commercialization of the above product;
WHEREAS, Roche and its Affiliates collectively have rights to the above
product, including the trademarks; and
WHEREAS, Connetics desires to acquire rights to the above product in the
United States of America and Roche desires to divest such rights.
NOW, THEREFORE, for and in consideration of the mutual covenants set forth
herein, Roche and Connetics agree as follows:
ARTICLE 1 - DEFINITIONS
The following terms used in this Agreement shall have the meaning set
forth in this Article:
1.1 "Affiliate" means:
(i) an organization of which greater than fifty percent (50%) of the
voting stock is controlled or owned, directly or indirectly, by
either Party to this Agreement;
(ii) an organization which directly or indirectly owns or controls
greater than fifty percent (50%) of the voting stock of either Party
to this Agreement; or
(iii) an organization, the majority ownership of which is directly or
indirectly common to the majority ownership of either Party to this
Agreement.
Anything to the contrary in this paragraph notwithstanding, Genentech,
Inc., a Delaware corporation, and Chugai Pharmaceutical Company, Ltd shall
not be deemed an Affiliate of Roche.
1.2 "Agreement" means this Sale and Purchase Agreement.
1.3 "API" means active pharmaceutical ingredient.
1.4 "Assets" has the meaning ascribed to such term in Section 2.1.
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1.5 "Assumed Liabilities" has the meaning ascribed to such term in Section
3.6.
1.6 "Closing" means the event defined in Section 8.4 and "Closing Date" means
the date of the event defined in Section 8.4.
1.7 "Domain Names" means the domain names that are registered in the name of
Roche and listed in Schedule 1.7.
1.8 "FDA" means the United States Food and Drug Administration.
1.9 "HSR Act" shall have the meaning ascribed in Section 8.1 of this
Agreement.
1.10 "IDP" means the intermediate drug product, which is the API plus
excipients after milling and spray drying.
1.11 "IND" means investigational new drug application number IND 25,782, filed
January 25, 1985. For purposes of this Agreement, the term "IND" includes
all correspondence with the Food and Drug Administration relating to the
IND.
1.12 "Inventory" means all finished goods inventory (finished, packaged, ready
for sale Product, including sample packs and starter packs) in the
Territory or destined for sale in the Territory as of the Closing Date, as
listed in Schedule 4.1.
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1.13 "NDA" means new drug application number NDA 19-821, filed February 26,
1988. For purposes of this Agreement, the term "NDA" includes all
correspondence with the Food and Drug Administration relating to the NDA,
and earlier filed (but withdrawn) new drug applications.
1.14 "NDC" means the National Drug Code assigned to a drug product listed under
Section 510 of the Federal Food, Drug, and Cosmetic Act.
1.15 "Product" means a product as sold in connection with the Trademark and
having the API acitretin.
1.16 "Related Marks" means trademarks listed in Schedule 1.16.
1.17 "Signing Date" shall mean the date this Agreement becomes fully executed
by both Parties.
1.18 "Transfer Know-How" means any and all technical data and records necessary
to enable Connetics to manufacture and sell the Product, market research
and information owned or controlled by Roche that is related solely to the
Product, API and/or IDP, as identified in Exhibit 1.
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1.19 "Trademark" means the trademark Soriatane(R) in the Territory and the
goodwill associated therewith.
1.20 "Territory" means the United States of America, including its territories.
1.21 In the definitions, the singular shall include the plural and vice versa.
ARTICLE 2 - TRANSFER OF ASSETS
2.1 Assets.
(a) Subject to the terms and conditions of this Agreement, Roche shall
assign and shall deliver to Connetics at Closing all of Roche's right, title and
interest in and to (i) the Trademark and the Related Marks, (ii) the Domain
Names, (iii) the NDA, (iv) the IND, (v) all Transfer Know-How and intellectual
property related to the Product, (vi) the drug master files for the Product and
the API in the Product (or, alternatively, written authorization for Connetics
to reference the applicable drug master files), (vii) the Psoria-Sense(R)
consumer database related to the Product, to the extent that Roche has a legal
right to transfer the database, and (viii) all Inventory (collectively, the
"Assets"), free of any encumbrances other than the Assumed Liabilities.
(b) The rights granted under this Agreement are limited to the Territory.
Accordingly, unless Roche gives its prior written consent, Connetics shall avoid
making sales that would likely result in Product being shipped or sold outside
the Territory, and shall use commercially reasonable efforts to prevent Product
from being shipped or sold outside the Territory.
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(c) As Roche will continue to manufacture pharmaceutical products
containing acitretin or etretinate as an active ingredient and to sell such
pharmaceutical products under the Tigason or NeoTigason trademark outside of the
Territory, Roche shall avoid making sales that would likely result in such
pharmaceutical products or their active pharmaceutical ingredients being sold
for end use in the Territory or shipped into the Territory as the ultimate
destination, and shall use commercially reasonable efforts to prevent such
pharmaceutical products from being sold for end use in the Territory or shipped
into the Territory as the ultimate destination.
(d) Except as expressly stated herein, Roche does not, under this
Agreement, convey any interest in any assets not expressly listed in this
Article 2.
2.2 Perfecting Rights.
(a) Roche shall as soon as reasonably practicable after the Closing Date
provide Connetics with the Transfer Know-How and shall execute any document
necessary to perfect in Connetics the ownership rights in the Trademark and the
Related Marks, NDA, IND, and Domain Names, as described in Section 2.1.
Connetics shall have the right to use Transfer Know-How to make, have made, use,
import and sell the Product in the Territory.
(b) (i) Subject to clause (ii) below, as of the Closing Date,
Roche hereby assigns to Connetics all of its rights, title,
interests and claims in, and with respect to, its rights under
all contracts, including managed care contracts, to which
Roche is a party related to the Product in the Territory to
Connetics, as identified in Schedule 7.6.
(ii) Notwithstanding anything in this Agreement to the contrary,
Roche shall not be required to assign any contract, claim, or
right arising thereunder or
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resulting therefrom if an attempted assignment thereof,
without the consent of a third party thereto, would constitute
a breach of such contract, claim, or right. However, Roche
shall cooperate with Connetics, in all reasonable respects, to
provide to Connetics the benefits under any such contract,
claim or right.
2.3 Roche Housemarks. Roche grants to Connetics for a period of one (1)
year beginning on the Closing Date (or such longer period as shall be necessary
to exhaust the Inventory, but in no event later than eighteen (18) months after
the Closing Date) permission for Connetics to use Roche trademarks, including
the Roche hexagon, that appear on existing Product packaging materials in the
Inventory and related package inserts and marketing, sales, instructional and
other accompanying literature existing as of the Closing Date ("Roche
Housemarks") solely for the purpose of allowing Connetics to sell such Inventory
and distribute such literature during such period. Connetics shall not use the
Roche Housemarks other than as they appear on materials in Inventory existing as
of the Closing Date. The Roche Housemarks include the logo depicted in Exhibit 2
(the "Roche Avoid Pregnancy Logo"). If the FDA should require Connetics to
continue using the Roche Avoid Pregnancy Logo on Product labeling, then Roche
shall grant Connetics a fully paid-up license to use the logo solely on Product
labeling for so long as the FDA requires Connetics to use the logo as part of
the Product labeling, subject to the terms and conditions of a trademark license
agreement to be negotiated in good faith by the Parties.
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2.4 Technology Transfer. Roche shall transfer to Connetics, at no
additional cost to Connetics, such manufacturing technology and Transfer
Know-How so as to permit Connetics or another entity to manufacture and test
Product and the API and IDP in the Product, and Roche agrees to fully and
promptly cooperate with Connetics to facilitate the transition. Roche agrees to
continue to provide such assistance to Connetics until September 30, 2004. Such
assistance shall not exceed thirty-five (35) person-days unless the Parties
agree otherwise. In addition to the coordination process described in Section
3.5, the Parties shall form a technology transfer committee with representatives
from each company to facilitate the transfer of the Transfer Know-How.
ARTICLE 3 - RESPONSIBILITIES AND COORDINATION
3.1 Product Approval Efforts. Connetics, at its sole cost, shall be solely
responsible for obtaining any approvals that may be necessary for transferring
the Product to Connetics. Moreover, Connetics as soon as practicable (but not
later than thirty (30) days after the Closing Date) shall assume full
responsibility for maintaining the NDA including without limitation complying
with FDA reporting requirements with respect to the Product. Roche agrees to
provide all documents that Connetics may need to support any such necessary
approvals for transferring the Product to Connetics. Roche will continue to
perform all required stability testing for all batches of Product manufactured
by Roche prior to the Closing Date, at no additional cost to Connetics. Roche
will provide to Connetics all necessary information in Roche's possession or
control for the first annual report, which will be prepared and submitted by
Connetics. Each Party shall furnish the other Party with an annual update
regarding the regulatory status of the Product for their respective territories.
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3.2 Marketing and Commercial Operations.
(a) As of the Closing Date, Connetics, at its sole cost, shall be solely
responsible for the marketing, distribution and sale of the Product in the
Territory. No later than the Closing Date, Roche shall supply to Connetics all
marketing materials then currently available and in use solely for the Product,
together with all available past marketing materials, marketing research
materials, and sales operations records and training materials that are solely
related to sale of the Product. If no training materials solely related to the
Product are available, then Roche shall provide redacted training materials
relevant to the Product. For avoidance of doubt, Roche shall not redact sales
operations records and will not provide any sales operations records that relate
to products other than the Product even if such records also pertain to the
Product.
(b) Commercial Operations Transferred in One Month. Subject to the
indemnification provisions in Article 6 below, and to the financial
administration provisions set forth in this Article 3, as soon as practicable
(but not later than one (1) month after the Closing Date, Connetics assumes sole
responsibility for the following activities with respect to the Product in the
Territory:
(i) administering sales, filling orders, and handling
distribution, inventory and receivables with respect to the
Product in the Territory; and
(ii) communicating with dispensers, distributors, end-users unless
Connetics solicits and Roche agrees to participate in such
communication.
(c) Commercial Operations Transferred in Two Months. Subject to the
indemnification provisions in Article 6 below, as soon as practicable (but not
later than two (2)
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months after the Closing Date), Connetics assumes sole responsibility for the
following actions with respect to the Product in the Territory:
(i) responding to product and medical questions and complaints relating
to the Product. Roche agrees that it shall refer any such complaints
which it receives to Connetics, as soon as reasonably practicable;
(ii) subject to Section 4.5, handling all recalls of the Product in the
Territory; provided however, recalls of any Product sold or
otherwise distributed by Roche other than to Connetics shall be the
responsibility of Roche and not Connetics; and
(iii) communicating with any governmental agencies and satisfying their
requirements regarding the authorization and/or continued
authorization to market the Product in commercial quantities in the
Territory, including obtaining NDC numbers.
3.3 Financial Matters.
(a) Accounting. All sales of Product on or after the Closing Date shall be
for the benefit of Connetics. Roche shall be entitled to all receivables accrued
prior to the Closing Date. The processing and financial responsibility for
returns, rebates and chargebacks shall be as set forth in this Section 3.3. The
Parties agree that for purposes of this Agreement, after the Closing Date, the
terms "returns," "rebates," and "chargebacks" shall have the same meaning as
Roche currentlyapplies, consistent with its current policies and practices and
with the financial information disclosed to Connetics during the due diligence
process.
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(b) Financial Administration.
(i) Net Receipts. For amounts billed by Roche on behalf of Connetics on
or after the Closing Date relating to Product order fulfillment,
Roche shall remit the related Net Receipts to Connetics on a monthly
basis as outlined in Section 3.3(d)(i). "Net Receipts" means the
amount invoiced by Roche on behalf of Connetics for sales of Product
in the Territory less two-and-a-half percent (2.5%) for expenses not
accounted for by Roche on a product-by-product basis, such as (i)
freight and insurance, or similar costs which are incurred by Roche
on behalf of Connetics as customary terms offered to customers for
the sale of Product, (ii) cash discounts, or similar costs which are
taken off invoice as customary terms offered to customers for the
sale of Product, and (iii) bad debt.
(ii) Rebates. Roche shall continue to process all rebates related to
sales of those NDC's of the Product supplied to Connetics under
Section 4.1. Roche shall process and pay for rebates in the ordinary
course of business consistent with its current policies. Roche shall
be financially responsible for rebates invoiced by any state
governments (1) in any quarter before the quarter in which the
Closing Date occurs, (2) in the quarter in which the Closing Date
occurs; and (3) in the first quarter after the quarter in which the
Closing Date occurs; and Connetics shall be financially responsible
for rebates invoiced by any state governments beginning two quarters
after the quarter in which the Closing Date occurs. For example, if
the Closing Date is March 1, 2004, then Roche shall be responsible
for rebates invoiced during the first and second quarters of 2004
(January through
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June 2004) and for any quarters prior those quarters, and Connetics
shall be responsible for rebates invoiced after June 30, 2004.
(iii) Notification of Third Parties. Roche shall notify all parties with
purchase contracts covering the NDC's of the Product supplied under
Section 4.1 that the contract will terminate as to those NDC's of
the Product in accordance with its terms as soon as commercially
practicable after the Closing Date. The Parties shall expeditiously
coordinate the transfer of Product sales under any government
contracts in accordance with the terms of those contracts and any
applicable government statutes and regulations.
(iv) Chargebacks. Roche shall continue to process and pay for all
chargebacks related to the Product until such time as Roche's
contract with a particular customer has terminated. Roche shall be
financially responsible for all chargebacks with an invoice date
(i.e., the date on which a wholesaler invoices the end customer)
within two (2) months following Closing ("Chargeback Tail Period");
and Connetics shall be financially responsible for all chargebacks
with an invoice date after the Chargeback Tail Period. Roche shall
process and pay for chargebacks in the ordinary course of business
consistent with its current policies.
(v) Industrial Funding Fee. Roche shall continue to process and pay for
all government-imposed fees, including the Industrial Funding Fee,
related to sales of the Product ("Government Fees") until Roche's
contracts with the government have terminated with respect to the
Product. Roche shall be financially responsible for all Government
Fees relating to sales of the Product until the Closing Date; and
Connetics shall be financially responsible for all Government
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Fees related to sales of the Product on or after the Closing Date.
Roche shall process and pay for Government Fees in the ordinary
course of business consistent with its current policies.
(c) Returns. For a period of three (3) months following the Closing Date
("Return Processing Period"), Roche shall continue to handle and process all
returns of the Product according to Roche's normal policies andprocedures (a
copy of which is attached as Exhibit 4. Any returns received directly by
Connetics during the Return Processing Period shall be forwarded to Roche's
designated facility at Roche's expense for handling of the returned Product and
processing of customer credits, unless the Product is in a condition that allows
it, under current good manufacturing practices of the FDA, as set forth in 21
C.F.R. Parts 210 and 211 ("GMP"), to be returned to inventory for resale
byConnetics, in which case Connetics shall return the Product to its inventory.
If the Product is returned to inventory for resale by Connetics or if the return
relates to one of the lots included in the Inventory, then Connetics will bear
the cost of the return and process the customer credit accordingly with no cost
chargeable to Roche. After the Return Processing Period, Connetics shall handle
all returns of the Product and process customer credits according to Connetics'
policies and procedures. Any returns received directly by Roche after the Return
Processing Period shall be forwarded to Connetics or Connetics' designated
facility at Connetics' expense for handling of the returned Product and
processing of customer credits. Neither Party shall take any action to
encourage, discourage, or delay the return of any Product.
(d) Processing Payments. Payments for Net Receipts, chargebacks, rebates,
fees and returns shall be processed as follows:
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(i) Net Receipts. Within fifteen (15) business days after the end of
each month, Roche shall send a report summarizing the calculation of
Net Receipts for such month. Roche shall remit to Connetics payment
for Net Receipts by wire transfer within thirty (30) business days
after the report is sent. Payment for Net Receipts shall continue so
long as Roche continues to invoice customers for sales of Product on
behalf of Connetics pursuant to Section 3.3(b)(i).
(ii) Rebates.
(A) Connetics Rebates. Within thirty (30) business days after the
end of each quarter, Roche shall send an invoice and a report
summarizing all rebates paid by Roche during that quarter (including
all related supporting documentation Connetics may reasonably
require), to the extent such amounts are owed by Connetics and paid
by Roche. If any government invoices for rebates relating to the
Product are received by Roche such that there is insufficient time
to process that invoice along with the other government invoices for
the quarter, then Roche shall defer invoicing Connetics for the late
government invoice until the next quarter and include the amount
invoiced in such late government invoice in Roche's invoice and
report to Connetics for the next quarter. Connetics shall remit
payment for such invoice, within thirty (30) business days after
receipt of such invoice.
(B) Roche Rebates. Within thirty (30) business days after the end of
each quarter, Connetics shall send an invoice and a report
summarizing all rebates paid by Connetics during that quarter
(including all related supporting documentation Roche may reasonably
require), if any, to the extent such amounts are owed by
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Roche and paid by Connetics. If any government invoices for
rebates relating to the Product are received by Connetics such
that there is insufficient time to process that invoice along
with the other government invoices for the quarter, then
Connetics shall defer invoicing Roche for the late government
invoice until the next quarter and include the amount invoiced
in such late government invoice in Connetics' invoice and
report to Roche for the next quarter. Roche shall remit
payment for such invoice within thirty (30) business days
after receipt of such invoice.
(iii) Chargebacks.
(A) During Chargeback Tail Period. If Connetics is charged for
any chargebacks during the Chargeback Tail Period, then
Connetics shall submit an invoice for the chargebacks with
reasonable supporting information to Roche, and Roche shall
reimburse Connetics for such chargebacks. Roche shall remit
payment for any such invoice within thirty (30) business days
after receipt of the invoice from Connetics.
(B) After Chargeback Tail Period. If Roche is charged for any
chargebacks after the Chargeback Tail Period, then Roche shall
submit an invoice for the chargebacks with reasonable
supporting information to Connetics, and Connetics shall
reimburse Roche for such chargebacks. Connetics shall remit
payment for any such invoice within thirty (30) business days
after receipt of the invoice from Roche.
(iv) Returns. Notwithstanding anything in this Article 3 to the
contrary, Roche shall continue to be financially responsible
for a period of six (6) months after the
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Closing Date for returns of Product from Lots produced and
sold by Roche prior to the Closing Date; provided, however,
that Roche's exposure shall be limited to a maximum of
$850,000. If aggregate returns attributable to Roche up to the
end of the six (6) month period exceed $850,000, then
Connetics will bear the incremental cost of Product returns.
Thirty (30) days after the end of each calendar quarter after
the Closing Date, Connetics shall send Roche an invoice for
all Product returns for which Roche is financially responsible
pursuant to this section 3.3(d)(iv), and Roche shall reimburse
Connetics for such returns at a rate equal to ninety percent
(90%) of Roche's wholesale acquisition price of Product as of
the Signing Date. Consistent with Roche's return policies,
Roche shall reimburse Connetics for partial returns on a pro
rata basis; for example, for a 50% partial return, Roche shall
reimburse Connetics for forty-five percent (45%) of Roche's
wholesale acquisition price of Product as of the Signing Date
(i.e., 90% of 50%). For returns related to partial lots
allocated as set forth in Section 3.3(e), Connetics' invoice
to Roche shall calculate Roche's percentage allocation.
(v) Industrial Funding Fee. Within sixty (60) business days after
the end of each quarter, Roche shall send an invoice and a
report summarizing all Government Fees paid on behalf of
Connetics for that quarter (including all related supporting
documentation Connetics may reasonably require), to the extent
such amounts are owed by Connetics and paid by Roche.
Connetics shall remit payment for such invoice, within thirty
(30) business days after receipt of such invoice.
(e) Lot Allocation. If the Inventory includes a partial lot of finished
goods, Roche and Connetics will allocate financial responsibility for the
returns of Product within lots
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according to a formula which calculates the ratio of (x) units of Product sold
from the lot before the Closing Date or (y) units of Product sold from the lot
on or after the Closing Date, divided by (in either case) (z) the total units of
Product in the lot.
(f) Sales and Pricing Information. Both Parties shall exchange sales and
pricing information related to sales of Product to the extent that such
information is needed to comply with this Agreement or a Party's government
reporting obligations.
3.4 Medical Questions. For up to two (2) months after the Closing Date
both Parties shall coordinate responses to questions and complaints regarding
the Product, with Connetics assuming complete responsibility at the earliest
possible date. After such two (2) month period (or earlier assumption of
responsibility by Connetics), Connetics shall be solely responsible for
responding to all medical questions or complaints and Roche shall immediately
refer any such medical questions or complaints, including all notices of adverse
findings, adverse event files and safety reports, to Connetics for handling.
Roche shall promptly transfer to Connetics its medical communications databases
related to the Product, and shall cooperate fully with Connetics to transition
the responsibility to Connetics. The Parties agree to enter into a separate
pharmacovigilance agreement regarding the reporting of adverse events and the
coordination of medical communications between Roche (for sales outside of the
Territory) and Connetics (for Product sold in the Territory).
3.5 Coordinators. To encourage a prompt and efficient transfer of
responsibility and for obtaining FDA approval, the Parties shall each appoint
one (1) authorized representative between whom communications will be conducted
("Coordinator"). Each Party will notify the
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other as to the name of the representatives so appointed. Either Party may
appoint a new Coordinator at any time, upon written notice to the other Party.
The Coordinators may confer and periodically meet to coordinate the transfer of
the Product from Roche to Connetics. The Coordinators may not obligate the other
Party in any way, financially or legally, with respect to the transfer of the
manufacture of the Product, obtaining or maintaining FDA approval of the Product
or commercialization of the Product. It is anticipated that the transfer of all
commercial and regulatory responsibilities relating to the Product will be
completed on or before December 31, 2004.
3.6 Apportionment of Liabilities. Subject to Article 6, Connetics shall
assume and be responsible for all liabilities related to the Product (including
Product that is used, sold or distributed on behalf of Connetics by Roche) and
the use of the Assets incurred on or after the Closing Date, including any cost,
claim, expense, loss or liability arising from any product liability claim or
lawsuit or any FDA or other governmental agency action or notification relating
to actions taken or omissions to act from and after the Closing Date (except to
the extent that the cost, claim, expense, loss or liability claimed relates to a
Product supplied to Connetics by Roche where the claim arises from the
manufacture of the Product) (collectively the "Assumed Liabilities"). Roche
shall retain and be responsible for all liabilities related to the Product and
the use of the Assets incurred before the Closing Date, including unripened
liabilities due to past actions or sales (collectively the "Retained
Liabilities").
3.7 Costs. Unless otherwise stated, it is the intention of the Parties
that obligations of Roche to cooperate and facilitate the transfer of the Assets
to Connetics pursuant to this
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Agreement shall be done at no additional cost to Connetics, assuming that the
activities and actions requested of Roche to facilitate such transfer are
commercially reasonable under the circumstances.
ARTICLE 4 - SUPPLY OF PRODUCT
4.1 Product Inventory Supply. As soon as practicable, Roche shall provide
to Connetics or its delegate all Inventory, including the supply of existing
Product designated for sale in the Territory then in the possession and control
of Roche which have thereon labeling prepared by Roche. Schedule 4.1 sets forth
the Inventory being transferred to Connetics under this Agreement and the price
to be paid by Connetics for the Inventory. Schedule 4.1 shall be updated as of
the Closing Date to reflect any shipments by Roche between the Signing Date and
the Closing Date.
4.2 Continuing Product Supply. In order for Roche to provide the current
versions (subject to labeling changes to reflect Connetics as Product owner) of
Product to Connetics, by no later than the Closing Date, Connetics and Roche
shall enter into a supply agreement (the "Supply Agreement") and corresponding
quality agreement (the "Quality Agreement") containing typical terms and
conditions to be negotiated in good faith. Subject to the terms and conditions
of the Supply Agreement, Connetics shall have the right at any time before
December 31, 2004, to order and specify the manufacturing and delivery date for,
and Roche shall supply to Connetics, as much Product as Connetics reasonably
requires to meet the projected demand for Product (provided that such demand
does not exceed Roche's capacity), at a price set forth in Schedule 4.1. After
2004, Roche shall not be obligated to supply Connetics with Product.
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4.3 API and IDP Supply. Roche shall continue to store, under suitable
conditions, in accordance with the terms and conditions of the Quality
Agreement, API and IDP through December 31, 2004. Connetics shall have the
option at any time before December 31, 2004, to order and specify the
manufacturing and delivery date for, and Roche shall supply to Connetics,
sufficient (in Connetics' reasonable determination, but not to exceed Roche's
capacity) API and IDP to enable Connetics to transfer the manufacture of Product
to a third party with no interruption of Product supply.
4.4 Shipment. All shipments of Inventory to Connetics under Article 4 will
be Ex Works (Incoterms 2000) Nutley, New Jersey. Roche will cooperate fully and
promptly with Connetics to make arrangements for the transfer of Inventory after
the Closing to a location that Connetics designates. Shipment terms for Product,
API and IDP purchased pursuant to Sections 4.2 and 4.3 shall be defined in the
Supply Agreement.
4.5 Defective Product. Within thirty (30) days from receipt by Connetics
of any shipment of API, IDP or Product by Roche under this Article 4, Connetics
may notify Roche in writing of Connetics' claims that part or all of the Product
shipment fails to meet cGMP, NDA or Product registration requirements,
specification or quality standards ("Notice of Defect"). The basis for such
claims, and the process for resolving them, shall be as set forth in the Supply
Agreement and the associated quality agreement.
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4.6 Recalls. If either Connetics or Roche believes a recall of a Product
provided to Connetics under Section 4.1 is required or desirable, the Parties
shall cooperate fully and promptly regarding the investigation and disposition
of such matter. If any recall of a Product is agreed by the Parties or required
by any governmental authority, the cost of such recall shall be borne by the
Party(s) which has caused the conditions causing such recall. The other Party
shall be entitled to such credits, replacements, reimbursements and allowances
from the causing Party as shall be necessary in order to assure that all cost
reasonably incurred by the other Party to effect such recall are paid or
reimbursed by the causing Party.
ARTICLE 5 - PAYMENTS
5.1 Payment. Connetics shall pay to Roche a total of one hundred and
twenty-three million dollars ($123,000,000) on the Closing Date.
5.2 Inventory Payments. Connetics shall buy the Inventory pursuant to
Section 4.1 (less any amounts shipped by Roche between the Signing Date and the
Closing Date) and will make the payment to Roche within thirty (30) days after
Connetics receives such Inventory. The cost for Inventory is set forth in
Schedule 4.1.
5.3 Supply Payments. Connetics shall pay Roche for any supply of Product
delivered subject to the terms and conditions of any supply agreement entered
into by the Parties.
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5.4 Payment. All payments due hereunder shall be paid by wire transfer to:
Xxxxxxxx-Xx Xxxxx Inc.
Account Xx. 00000000 xx
Xxxxxxxx, X.X., Xxx Xxxx, XX
ABA Routing No. 000000000
Payments not made within thirty (30) days after they are due shall be subject to
interest at the highest rate permitted by law commencing as of the due date.
ARTICLE 6 - INDEMNIFICATION
6.1 Product Liability. Without limiting any of the obligations of either
Party under this Agreement, each Party shall indemnify and hold harmless the
other Party, the other Party's past, present and future directors, officers,
employees and agents and all persons acting on their behalf, from and against
any and all losses, claims, obligations, liens, encumbrances, liabilities,
penalties, causes of action, costs and expenses (including, without limitation,
costs and expenses of defense, orders, judgments, fines, amounts paid in
settlements and reasonable attorneys' fees and expenses), and damages,
including, without limitation, injury to or death of persons (including, without
limitation, employees or agents of either Party) and/or damage to or loss
(including, without limitation, loss of use of or destruction of any property
(including without limitation, property of Roche or Connetics, or their
respective employees or agents)) whether the foregoing are based in contract,
warranty, negligence, strict liability, other tort, or any other legal theory,
in connection with any of the activities contemplated or encompassed under this
Agreement, arising out of, or incident to, (a) in the case of Roche, the
negligent act or omission of Roche, its past, present and future directors,
officers, employees and agents and all persons acting on their behalf ("Related
Parties"), with respect to the Product provided under
22
Section 4.1, including the manufacture by Roche and its Related Parties of the
Product provided under Section 4.1, (b) also in the case of Roche, the research,
manufacture, use or sale of Product by Roche and its Related Parties before the
Closing Date, or (c) in the case of Connetics, the manufacture, use or sale of
Product by Connetics, its past, present and future directors, officers,
employees and agents and all persons acting on their behalf, on or after the
Closing Date, unless such Product is manufactured by Roche, in which case Roche
shall be responsible for such manufacture to the extent it is solely within
Roche's control.
6.2 Handling. Subject to Section 6.1, each Party assumes the
responsibility of any personal injury or property damage arising from its own
handling and own use of the Product.
6.3 Notice. Whenever any claim shall arise for indemnification under
Section 6.1, the Party being indemnified ("Indemnitee") shall promptly notify
the indemnifying Party ("Indemnitor") of the claim and, when known, the facts
constituting the basis for such claim ("Notice"). The Indemnitee shall not
settle or compromise any claim by a third party for which it is entitled to
indemnification hereunder without the prior written consent of the Indemnitor
(which shall not be unreasonably withheld) unless suit shall have been
instituted against the Indemnitee and the Indemnitor shall not have taken
control of such suit after notification thereof as provided in Section 6.4.
6.4 Defense. In connection with any claim giving rise to indemnity
hereunder resulting from or arising out of any claim or legal proceeding by a
person who is not a party to this Agreement, the Indemnitor at its sole cost and
expense, may, upon written notice to the
23
Indemnitee, assume the defense of any such claim or legal proceeding if it
acknowledges to the Indemnitee in writing its obligations to indemnify the
Indemnitee with respect to all elements of such claim. Such acknowledgment shall
be without prejudice to establishing that no obligation to indemnify exists
during such legal proceedings. The Indemnitee shall be entitled to participate
in (but not control) the defense of any such action, with its counsel and at its
own expense. If the Indemnitor does not assume the defense of any such claim or
litigation resulting therefrom, (a) the Indemnitee may defend against such claim
or litigation, after giving notice of the same to the Indemnitor, on such terms
as the party may deem appropriate, and (b) the Indemnitor shall be entitled to
participate in (but not control) the defense of such action, with its counsel
and at its own expense. If the Indemnitor thereafter seeks to question the
manner in which the Indemnitee defended such third party claim or the amount or
nature of any such settlement, the Indemnitor shall have the burden to prove by
clear and convincing evidence that the Indemnitee did not defend or settle such
third party claim in a reasonably prudent manner.
6.5 Liability for Inventory. Roche shall assume the risk of loss in
respect of Inventory in Roche's possession and control after the Closing Date
but before shipment of the Inventory pursuant to Section 4.4, at which point the
risk of loss shall shift to Connetics.
6.6 No Special Damages. IN NO EVENT SHALL EITHER PARTY BE LIABLE TO THE
OTHER PARTY FOR ANY LOST PROFITS OR PUNITIVE, SPECIAL, INCIDENTAL, INDIRECT OR
CONSEQUENTIAL DAMAGES, EXCEPT THAT THE FOREGOING LIMITATION SHALL NOT APPLY TO
ANY LOST PROFITS OR PUNITIVE DAMAGES THAT MAY BE AWARDED TO A THIRD PARTY AND
FOR WHICH A
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PARTY OTHERWISE IS LIABLE TO PROVIDE INDEMNIFICATION UNDER THIS ARTICLE 6.
ARTICLE 7 - REPRESENTATIONS AND WARRANTIES
7.1 Authority. Each Party warrants and represents that it has the
authority to enter into this Agreement and to carry out the terms and
obligations hereunder. Each Party warrants and represents that it has obtained
all necessary consents and approvals, and performed all requisite corporate
action necessary to duly authorize the execution, delivery and performance of
this Agreement. Each Party warrants and represents that this Agreement is a
legal, valid and binding obligation of the respective Party, enforceable against
it in accordance with the terms of this Agreement.
7.2 Regulatory Approvals. Roche represents that to its knowledge, as of
the Signing Date, the NDA described in Section 1.14 is in full force and effect
and Roche has received no notice from the FDA that challenges or questions the
status of the NDA. The documents (including adverse events reported to the FDA)
listed on Exhibit 1, copies of which have been previously delivered or made
available to Connetics, include all material regulatory issues with respect to
the Product. Such copies are true and correct in all material respects.
7.3 Litigation.
(a) Roche represents that as of the Signing Date, to the best of its
knowledge, (i) there is no pending Proceeding (as defined below), (ii) other
than as disclosed to Connetics during the due diligence process, no person has
threatened to commence any Proceeding, and (iii) there is
25
no basis for any Proceeding, that (A) relates to or might affect any of the
Assets, or (B) challenges, or may have the effect of preventing, delaying,
making illegal or otherwise interfering with, any of the transactions
contemplated by this Agreement. To the best of Roche's knowledge, no event has
occurred, and no claim, dispute or other condition or circumstance exists, that
might directly or indirectly give rise to or serve as the basis for the
commencement of any such Proceeding. For purposes of this Agreement,
"Proceeding" means any action, suit, litigation, arbitration, proceeding
(including any civil, criminal, administrative, investigative or appellate
proceeding and any informal proceeding), prosecution, contest, hearing, inquiry,
inquest, audit, examination or investigation commenced, brought, conducted or
heard by or before, or otherwise involving, any governmental body or any
arbitrator or arbitration panel.
(b) To the best of Roche's knowledge, during the last eight years, there
has not been any occurrence of, nor is there under consideration or
investigation by Roche of, any Product recall, or post-sale warning conducted by
or on behalf of Roche concerning the Product or any Product recall conducted by
or on behalf of any entity as a result of any alleged defect in any Product.
7.4 Inventory. The Inventory of finished goods set forth in Schedule 4.1,
as of January 22, 2004, is of a type, quality and quantity useable and saleable
(without discount in excess of discounts customarily provided by Roche) in the
ordinary course of business related to the Product. The Product has a minimum of
twenty-four (24) months shelf life as of the Closing Date. Roche represents to
Connetics that Tigason(TM)-brand etretinate and any Roche product containing
etretinate are no longer commercially available in the Territory, and covenants
that Roche will not in the future commercialize those products in the field of
dermatology in the
26
Territory or grant any rights to another party to commercialize those products
in the field of dermatology in the Territory.
7.5 Product Formulas. As of the Closing Date, Roche shall have provided
Connetics with the current formulations and production methodologies of the
Product, which are sufficient to enable Connetics to manufacture the Product as
it is currently manufactured by or on behalf of Roche including, without
limitation, all existing information in written or electronic form that relates
to chemical processes for the production of API and intermediates in the
preparation of the Product, the in-process analytical controls for the
production of the API and the Product, the process, formulation and development
reports generated for the preparation of the Product, the analytical methods and
validation for the quality control release of the API and the Product, and the
stability protocols, stability indicating methods and stability dates for the
API and the Product.
7.6 Contracts. Schedule 7.6 sets forth a list of all contracts which
relate solely to the Product in the Territory. Connetics shall have no
responsibility or liability for contracts related to Soriatane which are not
listed on Schedule 7.6.
7.7 Intellectual Property. To the best of Roche's knowledge, there are no
infringements, threats of infringements or asserted or unasserted claims by
Roche of infringements or misappropriation of any intellectual property in the
Territory with respect to the Product, nor are there any asserted or unasserted
claims by Roche contesting or challenging the
27
right, title, or interest of any other person in any of the intellectual
property relating to the Product, including the Trademarks, Domain Names, or
Transfer Know-How.
7.8 Ordinary Course. From December 1, 2003, through the Signing Date,
Roche has conducted the business relating to the Assets only in the ordinary
course and there have been no events or circumstances of any kind that have
materially and adversely affected the business related to the Assets. In
particular, without limiting the general nature of the foregoing statement,
Roche shall not have transferred any inventory except in the normal course,
shall have continued to meet the contractual obligations of the Assets as they
mature in the normal course, and shall not have implemented any price increases
or decreases for the Product or any new trade or consumer promotions, nor
changed the terms or conditions of any such promotion. Notwithstanding the
above, Connetics acknowledges and understands that Roche has dismissed its sales
force and discontinued marketing and promotion of the Product. Roche shall
update Schedule 4.1 to reflect the shipments of Product made between the Signing
Date and the Closing Date, and Roche shall provide Connetics with backup
information showing weekly Product shipments from the Signing Date through the
Closing Date. Roche shall also furnish Connetics with a current record, accurate
as of the Signing Date, of the unit sales of Product for the month of December
2003 and for the period from January 1, 2004, through the Signing Date.
7.9 Limitation of Warranty and Disclaimers. EXCEPT FOR THE WARRANTIES
EXPRESSLY SET OUT IN THIS AGREEMENT, ROCHE MAKES NO WARRANTY OR REPRESENTATION
WHATSOEVER, EXPRESS OR IMPLIED, WITH RESPECT TO THE ASSETS TRANSFERRED TO
CONNETICS HEREUNDER. TRANSFER KNOW-HOW IS
28
BEING PROVIDED TO CONNETICS WITH NO WARRANTIES, EXPRESSED OR IMPLIED, INCLUDING
ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. PRODUCT IS
BEING PROVIDED WITH NO WARRANTIES, EXPRESSED OR IMPLIED, INCLUDING ANY WARRANTY
OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE (OTHER THAN THAT THE
PRODUCT IS FIT FOR THE PURPOSE SET FORTH IN THE NDA). ROCHE MAKES NO
REPRESENTATION OR WARRANTY AS TO THE PROSPECTS, FINANCIAL OR OTHERWISE, FOR
MARKETING THE PRODUCT IN THE TERRITORY. ROCHE DOES NOT WARRANT OR REPRESENT THAT
SUBSTANTIALLY SIMILAR OR IDENTICAL PRODUCTS WILL NOT BE REGISTERED AND SOLD IN
THE TERRITORY. EXCEPT AS OTHERWISE STATED HEREIN, ROCHE MAKES NO REPRESENTATION
OR WARRANTY REGARDING ITS OR ANY THIRD PARTY'S INTELLECTUAL PROPERTY RIGHTS
(INCLUDING PATENT AND TRADEMARK RIGHTS) RELATING TO THE USE, MANUFACTURE OR SALE
OF THE PRODUCT.
7.10 Risks. While Roche shall cooperate with Connetics in accordance with
Article 3, Roche, inter alia, can not ensure Connetics' ability to (i) obtain or
maintain FDA approval to commercialize the Product, (ii) successfully
manufacture the Product or (iii) market the Product to obtaining any level of
sales. Connetics agrees that Roche does not assume any risks or responsibility
for Connetics obtaining or not obtaining any sales of the Product for any reason
other than breach of the representations or warranties set forth in this Article
7.
29
7.11 Due Diligence. Connetics warrants and represents that Connetics has
conducted a due diligence investigation concerning the Assets and concerning the
Product.
7.12 Financing. Connetics warrants and represents that as of the Signing
Date, it has sufficient funds and financial commitments to make the payment
called for by Section 5.1 of this Agreement, as well as the payments called for
by Sections 5.2 and 5.3. Connetics shall deposit into escrow the sum of Forty
Million Dollars ($40,000,000.00) no later than February 10, 2004. On the Closing
Date, the funds in the escrow account will be credited towards the payment
called for by Section 5.1.
7.13 Brokers. Connetics and Roche each warrant and represent that it has
not engaged any investment banker, broker, finder, intermediary, or the like in
connection with the transactions contemplated hereby who might be entitled to a
fee or any commission upon consummation of the transactions contemplated hereby.
7.14 HSR Act. Connetics and Roche each covenant to make any required
application pursuant to the HSR Act no later than ten (10) days after the
Signing Date. Roche covenants that it will cooperate fully and promptly in the
HSR notification process, and that it will promptly coordinate and cooperate
with Connetics in exchanging information and providing reasonable assistance as
Connetics may request in connection with the process.
30
ARTICLE 8 - CONDITIONS TO CLOSING AND CLOSING, AND POST-CLOSING COVENANTS
8.1 Conditions Subsequent. If the Xxxx-Xxxxx-Xxxxxx Antitrust Improvements
Act of 0000 (xxx "XXX Xxx") applies to the transactions contemplated by this
Agreement, the effectiveness of this Agreement and the transactions contemplated
hereunder shall be subject to and shall be contingent upon the satisfaction
under the following condition subsequent to the execution of this Agreement. The
condition subsequent shall be the earlier to occur of the approval of the
transaction by the Federal Trade Commission or the appropriate federal antitrust
authority, or the expiration or termination of all applicable waiting periods,
requests for information (and any extensions thereof) under the HSR Act. Subject
to the terms and conditions of this Agreement, each Party shall use all
reasonable efforts to take, or cause to be taken, all reasonable actions and to
do, or cause to be done, all things necessary and appropriate to satisfy the
condition subsequent and to consummate the transactions contemplated by this
Agreement in accordance with the terms hereof. Each Party shall cooperate with
the other Party in the preparation, execution and filing of all documents that
are required or permitted to be filed on or before the Closing Date for the
purpose of consummating this transaction, including, filings pursuant to the HSR
Act. Each Party shall bear its own costs with respect to preparing, executing
and filing such documents. Either Party may terminate this Agreement in its
entirety, upon ten (10) days prior written notice to the other Party if the
condition subsequent under this Section 8.1 has not been fulfilled within three
(3) months of the Signing Date, in which case, upon termination, there shall be
no liabilities for obligations on the part of either Party except if there has
been a breach of this Section 8.1.
31
8.2 Conditions Precedent for Connetics. The obligations of Connetics under
this Agreement to complete the transactions contemplated hereby are subject to
the satisfaction by Roche on or prior to the Closing of the following conditions
(all or any of which may be waived by Connetics in whole or in part but such
waiver shall be in writing):
(a) Representations and Warranties. The representations and warranties
made by Roche in this Agreement shall be true and correct in all material
respects as of the Closing with the same force and effect as though said
representations and warranties had been made on the Closing.
(b) Performance. Roche shall have performed and complied in all material
respects with all agreements, obligations and conditions required by this
Agreement to be so performed or complied with by it prior to or at Closing.
(c) Execution of Supply and Pharmacovigilance Agreements. Roche and
Connetics shall have entered into a Supply Agreement and a Quality Agreement as
described in Section 4.2, and a Pharmacovigilance Agreement as described in
Section 3.4.
8.3 Conditions Precedent for Roche. The obligations of Roche under this
Agreement to complete the transactions contemplated hereby are subject to the
satisfaction by Roche on or prior to the Closing of the following conditions
(all or any of which may be waived by Roche in whole or in part but such waiver
shall be in writing):
32
(a) Representations and Warranties. The representations and warranties
made by Connetics in this Agreement shall have been true and correct in all
material respects as of the Closing with the same force and effect as though
said representations and warranties had been made on the Closing.
(b) Performance. Connetics shall have performed and complied in all
material respects with all agreements, obligations and conditions required by
this Agreement to be so performed or complied with by it prior to or at Closing.
(c) Financial Condition. No material adverse change shall have occurred to
the financial condition of Connetics or the ability of Connetics to discharge
its obligations hereunder, from the Signing Date to the Closing Date.
8.4 The Closing. Subject to the satisfaction of all of the conditions to
each Party's obligations set forth in Article 8 hereof (or, with respect to any
condition not satisfied, the waiver in writing thereof by the Party or Parties
for whose benefit the condition exists), the closing of the transactions
contemplated by this Agreement (the "Closing") shall take place as soon as
possible following the execution of this Agreement and satisfaction of the
conditions to Closing set forth in Sections 8.1, 8.2 and 8.3 above at the
offices of Roche or its Affiliate or at such other time, date and place as the
Parties may agree in writing. The transfer of the Assets shall be deemed to have
occurred as of the Closing Date.
33
8.5 Deliveries by Roche. As soon as commercially practicable after the
Signing Date, Roche shall deliver to Connetics all physical embodiments of the
Assets (other than the Inventory, the transfer of which shall be coordinated
before the Closing Date), together with all tangible technical data,
formulations, Product literature and other documentation related to the Assets.
No later than thirty (30) days after the Closing Date, Roche shall deliver to
Connetics, in form reasonably satisfactory to Connetics, the remaining Assets
and executed assignments transferring ownership of the Assets, in recordable
form when necessary, and any other documents reasonably requested by either
party in order to carry out the intent of this Agreement. Notwithstanding the
preceding, with respect to the Trademark, Related Marks and Domain Names,
following the Closing, Connetics shall prepare and Roche shall execute documents
required in order to assign and record the assignment of the Trademark, Related
Marks and Domain Names.
8.6 Deliveries by Connetics. At Closing, Connetics shall deliver or cause
to be delivered to Roche the up-front payment in accordance with Section 5.1.
8.7 Effect of Closing. The transfer of the Assets shall be effective as of
the Closing Date, notwithstanding that some of the formalities necessary to
effectuate the transfer will not be accomplished until after the Closing. It is
understood and agreed that all revenues and costs for sale of Product in the
Territory prior to the Closing Date shall be for the account of Roche and all
revenues and costs on or following the Closing Date shall be for the account of
Connetics; and the Parties agree that they shall take such actions and do all
things necessary, including reconciling payments and reports, in order to carry
out this intent.
34
8.8 Post-Closing Covenants. No later than thirty (30) days after the
Closing Date, Roche shall furnish Connetics with financial information in such
form, audited and unaudited, as is necessary to satisfy the SEC's Regulation S-X
reporting requirements for Connetics with respect to the business related to the
Assets. If Roche does not maintain such information in the form required by the
SEC, Connetics shall pay Roche its reasonable cost for preparing such
information.
ARTICLE 9 - MISCELLANEOUS
9.1 Force Majeure. The performance by either Party of any covenant or
obligation on its part to be performed hereunder shall be excused if
contingencies beyond its control occur, such as strikes or other work stoppage,
lock-outs, riots, wars, whether war is declared or not, terrorism, acts of God,
invasion, fire, explosions, floods, storms, delay of carrier, and acts of
government or governmental agencies or instrumentalities. Each Party will notify
the other immediately should any contingency occur and of the period such
inability to perform is expected to continue. Both Parties will be excused of
their covenants and obligations during the period in which such inability to
perform exists.
9.2 Choice of Law. Any dispute regarding this Agreement shall be governed
by and interpreted in accordance with the laws of the State of New Jersey.
9.3 Notices. Any notice required or permitted to be given hereunder shall
be considered properly given if hand delivered or sent by nationally recognized
air courier,
35
signature confirmation requested, or by certified return receipt mail to the
respective address of each Party as follows:
Connetics Corporation
0000 Xxxx Xxxxxxxx Xxxx
Xxxx Xxxx, Xxxxxxxxxx 00000
Attention: President
With a copy to: General Counsel
and
Xxxxxxxx-Xx Xxxxx Inc.
000 Xxxxxxxxx Xxxxxx
Xxxxxx, XX 00000
Attention: Corporate Secretary
or to such other person or address as the addressee shall have last furnished in
writing to the addressor, with the notice to be effective upon receipt.
9.4 Press Releases
(a) Roche, no earlier than the date of the Closing Date, will issue a
press release intended to reach pertinent audiences which prescribe, dispense or
distribute the Product. The press release shall be subject to review and
approval by Connetics (which approval shall not be unreasonably withheld) and
shall advise of the transfer of the Product and the NDA to Connetics and the
availability of the Product from Connetics.
(b) In addition to the press release described in Section 9.4(a),
Connetics will issue a press release substantially identical to the press
release attached hereto as Exhibit 3 on a mutually agreed date after the Signing
Date (the "Initial Release"). Prior to issuing the Initial Release, Connetics
shall obtain consent and final approval from Roche of the Initial Release.
36
(c) Following the dissemination of the Initial Release, the Parties will
jointly agree upon any other press release and any other public announcement
which refers to this Agreement or to the relationship of the Parties. Each Party
shall obtain the other Party's prior written approval for such press releases
and public announcements, which approval will not be unreasonably withheld or
delayed. Such approval shall not be needed if a Party reasonably believes the
press release or public announcement is required by force of law. In such
instance the other Party shall have a reasonable opportunity to comment on the
proposed disclosure. Notwithstanding the foregoing or the provisions of the
Non-Disclosure Agreement, Roche acknowledges and agrees that Connetics may
publicly file a copy of this Agreement as an exhibit to its reports with the
U.S. Securities and Exchange Commission (the "SEC") if Connetics determines such
filing to be necessary, provided that (i) Connetics shall supply to Roche an
advance copy of the form of the Agreement as proposed to be filed with the SEC,
(ii) Connetics shall give Roche the opportunity to comment on such proposed
filing, and (iii) Connetics shall take all reasonable and lawful actions to
obtain confidential treatment with respect to the provisions of this Agreement
which Connetics or Roche reasonably deem to be competitively sensitive
information. Moreover, the Parties agree that Connetics may refer to Roche in
future filings and releases using language previously authorized by Roche,
without the need for securing Roche's additional approval.
9.5 Captions. All titles and captions in this Agreement are for
convenience only and shall not be of any force or substance.
37
9.6 Severability. In the event that a court of competent jurisdiction
holds that a particular provision or requirement of this Agreement is in
violation of any law, such provision or requirement shall not be enforced only
to the extent that it is in violation of such law and all other provisions and
requirements of this Agreement shall remain in full force and effect.
9.7 Expenses. Except as otherwise provided in this Agreement, all legal,
accounting and other costs and expenses incurred in connection herewith and the
transactions contemplated hereby shall be paid by the Party incurring such
expenses.
9.8 Amendments; No Waiver. No provision of this Agreement may be amended,
revoked or waived except by a writing signed and delivered by an authorized
officer of each Party. No failure or delay on the part of either Party in
exercising any right hereunder will operate as a waiver of, or impair, any such
right. No single or partial exercise of any such right will preclude any other
or further exercise thereof or the exercise of any other right. No waiver of any
such right will be deemed a waiver any other right hereunder.
9.9 Entire Agreement. This Agreement constitutes the entire agreement
between the Parties with respect to the subject matter hereof and supersedes all
previous agreements, whether written or oral, except for (a) the Non-Disclosure
Agreement, and (b) the Supply Agreement, the Quality Agreement and the
Pharmacovigilance Agreement to be entered into pursuant to Sections 3.4 and 4.2
of this Agreement. No modification or amendment hereof shall be of any force or
effect unless it is in writing signed by the parties to be bound thereby.
38
9.10 Counterparts. This Agreement may be executed in one or more
counterparts all of which shall together constitute one and the same instrument
and shall become effective when a counterpart has been signed and delivered by
Connetics and when a counterpart has been signed and delivered by Roche.
[Balance of Page Intentionally Blank]
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IN WITNESS WHEREOF, Connetics Corporation and Xxxxxxxx-Xx Xxxxx Inc. have
caused this Agreement to be duly executed by their authorized representatives on
the dates written below.
CONNETICS CORPORATION XXXXXXXX-XX XXXXX INC.
By: /s/ Xxxxxx X. Xxxxxxx By: /s/ Xxxxxx Xxxxx
------------------------- -----------------------------
Name: Xxxxxx X. Xxxxxxx Name: Xxxxxx Xxxxx
------------------------- -----------------------------
Title: President and CEO Title: Global Head of Business Dev.
------------------------- -----------------------------
Date: Date: February 16, 2004
------------------------- -----------------------------
40
