EXHIBIT 10.1
AMENDED AND RESTATED
MANUFACTURING AND SUPPLY AGREEMENT
This Amended and Restated Manufacturing and Supply Agreement is entered into
effective as of September 19, 2001, by and between Miza Pharmaceuticals (UK)
Limited, a company organized under the laws of England and Wales ("Miza"), and
Connetics Corporation, a Delaware corporation ("Connetics"). Miza and Connetics
are each referred to as a "Party" to this Agreement, and collectively as the
"Parties."
BACKGROUND
A. Connetics, under its former name Connective Therapeutics, Inc., and CCL
Pharmaceuticals, a division of CCL Industries Limited, a limited company
organized under the laws of England and Wales ("CCL"), are parties to a
Supply Agreement dated 01 June 1996, as amended February 1998 and 27
March 1998 (the "Original Agreement").
B. With respect to the business arrangement pursuant to the Original
Agreement, Miza is the successor in interest to CCL.
C. Effective April 20, 2001, Connetics acquired Soltec Research Pty Ltd.
("Soltec"), which was the licensor of the products that were the subject
of the Original Agreement.
D. Connetics desires to use Miza's facilities, resources and expertise to
manufacture the Products, as defined below, and Miza desires to act as a
contract manufacturer of the Product(s) agreed to by both Parties in
accordance with the terms and conditions set forth in this Agreement;
E. Miza and Connetics wish to amend and expand the scope of the Original
Agreement on the terms and conditions set forth in this Agreement, for
the consideration set forth in this Agreement.
NOW, THEREFORE, in consideration of the above premises and the mutual covenants
set forth below, Miza and Connetics agree as follows:
AGREEMENT
ARTICLE 1
DEFINITIONS
For the purposes of this Agreement, the following capitalized terms shall have
the following meanings:
"AFFILIATE" means any corporation or other business entity controlled by,
controlling or under common control with a party hereto. For this purpose
"control" shall mean direct or indirect
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beneficial ownership of fifty percent (50%) or more of the voting stock, or a
fifty percent (50%) or more interest in the income of, such corporation or other
business entity.
"BATCH" shall have the meaning set forth in the Quality Agreement.
"CERTIFICATE OF ANALYSIS" means a summary of the quality control testing, as
described in the Product Specifications, performed by Miza for Finished Product
supplied under this Agreement.
"CHANGE" shall have the meaning set forth in the Quality Agreement.
"cGMPs" means the current Good Manufacturing Practices of the FDA.
"COMMERCIALLY REASONABLE EFFORTS" means the effort by Miza or Connetics to
deploy, in light of prevailing circumstances and taking into account obligations
and commitments to third parties, sufficient resources, capital equipment,
material and labor as might reasonably be expected to achieve in a commercially
appropriate time-scale, the benefits which are reasonably anticipated to accrue
to Miza and Connetics from the commercial exploitation of the Products, and if
the Commercially Reasonable Efforts are to be directed to a specific goal, then
the achievement of that goal.
"CONFIDENTIAL INFORMATION" shall have the meaning set forth in SECTION 7.3 of
this Agreement.
"CONNETICS REPRESENTATIVE" means the person designated by Connetics who shall be
primarily resident on site at Miza's facility. As of the date of this Agreement,
[*] is designated as the Connetics Representative.
"DATE OF MANUFACTURE" shall have the meaning set forth in the Quality Agreement.
"DEVELOPMENT AGREEMENT" means any separate agreement entered into by the Parties
with respect to a potential Product that is not yet ready to be manufactured on
a commercial scale, including the requirements surrounding production of units
of Product and Placebo appropriately labeled for use in Connetics' clinical
trials (in amounts to be specified by Connetics, as required). Each such
Development Agreement shall, when executed, be appended to this Agreement as an
EXHIBIT D.
"DMF" means the Drug Master File for a Product, as filed by Miza with the FDA.
"FDA" means the Food and Drug Administration of the United States of America.
"FINISHED PRODUCT" shall have the meaning set forth in the Quality Agreement.
"IND" means an Investigational New Drug Application for a Product, as filed by
Connetics with the FDA.
"INITIAL TERM" shall have the meaning set forth in SECTION 10.1.
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"LABELING" means the primary container label, secondary packaging, package
insert, shelf pack and shipper label specific to a finished Product manufactured
in accordance with cGMPs and Connetics' instructions.
"LOSSES" shall have the meaning set forth in SECTION 11.1.
"MANUFACTURING STANDARDS" means the specifications for manufacturing, packaging,
labeling and storing the Products set forth in the Product Specifications, the
master batch record, cGMPs, MSDSs, and all other applicable U.S. laws and
regulations.
"MSDS" means material safety data sheet(s).
"NDA" means a New Drug Application for a Product, as filed by Connetics with,
and approved by the FDA.
"PLACEBO" means a Product adjusted to be formulated without the active
ingredient.
"PRODUCT SPECIFICATIONS" means the specifications provided by Connetics for the
manufacture of any Product.
"PRODUCT(S)" means the products described on EXHIBIT A to this Agreement, as it
may be properly amended from time to time by agreement of the Parties, and which
is incorporated by this reference as though fully set forth in this paragraph.
"QUALITY AGREEMENT" means the Agreement set forth as EXHIBIT C to this Agreement
and incorporated by this reference as though fully set forth in this Agreement.
"REGULATORY AUTHORITY" means the FDA or any equivalent or additional
governmental or regulatory agencies having jurisdiction with respect to Miza,
Miza's facilities, or the Products.
"UNIQUE MATERIALS" shall have the meaning set forth in SECTION 3.12 of this
Agreement.
ARTICLE 2
PRODUCT SPECIFICATIONS AND MANUFACTURE
2.1 Manufacture of Products. During the term of this Agreement, and subject
to the terms and conditions of this Agreement, Miza shall formulate,
fill and package the Products in accordance with their respective
Product Specifications, according to the terms of this Agreement and the
Quality Agreement, as they may be amended from time to time.
2.2 Conformance to Product Specifications. Products (and jointly approved
for the purposes of this section, the Placebo) shall conform to the
Product Specifications, the terms of the Quality Agreement, and all
specifications provided in Connetics' IND or NDA. Notwithstanding the
foregoing, if Connetics accepts Product in accordance with the
provisions of this Agreement and the Quality Agreement, this SECTION 2.2
shall be deemed to have been satisfied.
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2.3 Labeling. Miza will label and package Product in finished form, pursuant
to a firm purchase order accepted by Miza as described in SECTION 3.4,
provided, however, that Connetics shall be responsible for the
origination of artwork and text, as well as written final approval
before manufacture, of the Labeling.
2.4 Raw Materials. Miza shall have the sole responsibility to source all raw
materials used in manufacture of the Products, including all quality
control responsibility for such raw materials.
2.5 Batch Testing; Certificate of Authenticity. Miza shall test, or cause to
be tested, in accordance with the Product Specifications, each batch of
Product manufactured pursuant to this Agreement before delivery to
Connetics. Prior to each shipment of Product, Miza shall provide to
Connetics a Certificate of Analysis attesting to the quality of each
batch contained within the shipment, including review and approval by
the appropriate quality control unit of all batch production and control
records. Miza shall maintain and provide Connetics with such
documentation as may be required for compliance with FDA and other
applicable regulations.
2.6 Good Manufacturing Practice. Miza shall manufacture, store and prepare
all Products for shipping in accordance with cGMPs, and the equivalent
manufacturing requirements of the European Regulatory Authorities, as
applicable, in an FDA inspected and ISO9000 certified facility,
currently envisioned to be Miza's facility in Runcorn, U.K. Miza may not
change manufacturing of Products to an alternate facility without first
obtaining Connetics' written approval, including the approvals required
pursuant to the Quality Agreement, such approval not to be unreasonably
withheld.
2.7 DMF. To the extent required, Miza shall maintain a DMF or like filing,
suitable for Miza's manufacture of Products, with the applicable
regulatory agencies (including FDA) and shall ensure that its "active
status" is maintained. Miza shall use Commercially Reasonable Efforts to
timely accomplish, and bear the costs of, preparing for regulatory
inspection, approval and associated filings required for the manufacture
of Connetics' Products. Connetics shall directly pay or reimburse Miza
for any fees and payments to such regulatory agencies required for such
inspection, approval and associated filings (e.g., any FDA inspection
fee); it is understood that Connetics is not responsible for any
additional fees and payments related to the general operation of Miza's
business or facilities. Miza will provide letter(s) granting Connetics
and its designees the right of cross-reference to the DMF. Miza reserves
the right to cancel such letter(s) in case of termination of this
Agreement.
2.8 Inspections. Connetics has the right at any time during the term of this
Agreement, upon reasonable prior notice and during reasonable business
hours and without disruption to Miza's business, to inspect Miza's
facility, and to make FDA-type inspections at its plant to satisfy
itself that Miza manufactures and documents the Product according to
current cGMPs, consistent with FDA standards and requirements. Such
inspections may only be made by individuals reasonably acceptable to
Miza. The provisions of this SECTION 2.8
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are subject to the confidentiality provisions of ARTICLE 7. Connetics
shall be responsible for its costs of travel and accommodation for such
inspections.
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2.9 Changes to Product Specifications.
(a) If Connetics desires any material change to the Product
Specifications or manufacturing process, Connetics shall
deliver, [*] prior to the expected date of implementation,
written notice to Miza specifying such change desired by
Connetics, and Miza shall acknowledge in writing any such notice
within [*] days after Miza's receipt thereof; provided, however,
that the Product Specifications or process shall not be
supplemented, modified or amended in any respect without the
prior written agreement of the Parties. Miza will use
Commercially Reasonable Efforts to implement changes within [*]
after Miza's acknowledgement of such notice. If Connetics
requests a change to a Product Specification, including the
manufacturing process, and Miza agrees that such change is
feasible, such change shall be incorporated within the Product
Specification pursuant to a written amendment to this Agreement.
Connetics shall be responsible for obtaining any required FDA
approval prior to implementation of such a change at Connetics'
cost.
(b) Miza will communicate to Connetics in a timely manner any change
in the Product Specification, including the manufacturing
process, initiated by Miza, and will obtain Connetics' written
approval by way of written amendment of this Agreement
incorporating such change within the Product Specification prior
to implementation of the change. No such change may be
instituted except in compliance with this Agreement and the
Quality Agreement. Connetics shall have the option of obtaining,
or having Miza obtain any required FDA approval or other
regulatory approval prior to implementation of such a change.
Miza may provide additional services in conjunction with the
manufacture of Products, such as additional formulation, process
development or stability testing, at the request of Connetics
and pursuant to Connetics' purchase order, and all data and
results from such additional services shall be owned by
Connetics and protected as confidential under this Agreement.
2.10 Connetics Representative at Miza. Connetics may, at Connetics' expense,
place a company representative on-site at Miza's manufacturing facility
during the term of this Agreement. Subject to the following sentence,
such representative shall have full access to all operations, documents,
and records that specifically pertain to the manufacture of the
Products. The Connetics Representative shall accept Miza's procedures
regulating external customer relationships (including GMP training,
guarantee of confidentiality, and health procedures), and shall not
materially disrupt Miza's operations.
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ARTICLE 3
PLANNING AND SUPPLY
3.1 Production. Miza will produce Products to meet the mutually agreed upon
forecasts, subject to the provisions of this ARTICLE 3. Miza will keep
Connetics reasonably informed of all scheduled production activity for
the Products.
3.2 Termination of Obligation. Miza's obligation to supply Product to
Connetics shall terminate pursuant to the provisions of ARTICLE 10
below.
3.3 Forecasts. Connetics shall provide Miza with an annual forecast for
budgeting and production planning purposes. Connetics shall also deliver
to Miza a monthly update during the first calendar week of each month.
Each monthly update shall include a [*] setting forth Connetics'
required quantities and delivery dates for each Product, together with a
summary of changes from the previous update. Forecasts shall include the
amounts of each Product to be manufactured and supplied by Miza and the
expected timing for the delivery of each shipment during the forecast
period. The Parties shall discuss each of the forecasts and shall
mutually agree in good faith on the appropriateness of each forecast
versus anticipated demand for Product.
3.4 Purchase Orders. Connetics will place written purchase orders directly
or through its designated representatives with Miza approximately [*]
prior to requested shipment date, including the following details:
number of units, requested shipping date, shipping instructions and
Connetics' order reference number including the price calculated
according to this Agreement. Each Purchase Order issued pursuant to this
Agreement shall be governed by the terms and conditions of this
Agreement, and shall override any conflicting provisions in any purchase
order and any invoice or packing slip generated by Miza with respect to
the details set forth in this SECTION 3.4.
3.5 Receipt and Acceptance by Miza. Miza shall promptly acknowledge its
receipt of purchase orders and inform Connetics of the anticipated dates
of manufacture and delivery of each Product presentation to Connetics.
Miza shall respond in writing as to its acceptance of each firm purchase
order [*]. Once a specified quantity, form and delivery date terms have
been agreed to by the Parties in any purchase order placed pursuant to
this SECTION 3.5, the purchase order may not be canceled by either Party
except as provided in SECTION 3.10 or in SECTION 3.11 below.
3.6 Shipment; Delays. Miza shall use Commercially Reasonable Efforts to ship
Product to Connetics by the delivery date specified in the accepted
purchase order. If Miza believes there will be a significant delay in
shipment of Finished Product beyond the delivery dates specified in any
accepted purchase order, Miza shall promptly inform Connetics of such
expected delay and shall use Commercially Reasonable Efforts to minimize
the delay.
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3.7 Change Orders. The time of delivery and quantities specified in a
purchase order accepted by Miza pursuant to SECTION 3.5 above shall be
binding upon the Parties and may not be changed or canceled, except as
provided in SECTIONS 3.9 AND 3.10 below.
3.8 Increased Demand. Miza will use Commercially Reasonable Efforts to
accommodate Connetics' requests for units in excess of those reserved
for Connetics and set forth in EXHIBIT B to this Agreement; provided,
however, that it shall not be a breach of this Agreement if Miza,
despite its Commercially Reasonable Efforts, is unable to supply
quantities of Product to Connetics in excess of [*] of the annual
forecast supplied pursuant to SECTION 3.3 for that year.
3.9 Postponement of Manufacturing; Penalties.
(a) By Connetics. Connetics may postpone a purchase order for
production in accordance with the provisions in this Section.
Connetics may postpone each purchase order one time. In the
event of postponement pursuant to this SECTION 3.9, Miza shall
use Commercially Reasonable Efforts to reschedule the postponed
order to a date agreeable to both Parties. Regardless of the
amount of notice, if Connetics does not reschedule the Date of
Manufacture to a date within [*] of the originally scheduled
date, the Purchase Order shall be deemed cancelled, and
Connetics shall incur the penalties, if any, pursuant to SECTION
3.10.
(b) By Miza.
(i) Miza shall use Commercially Reasonable Efforts to meet
the terms of a purchase order that it accepts, taking
into account mutually agreed upon forecasts under
SECTION 3.3, available plant capacity and timing of its
production.
(ii) If Miza fails to meet the deadlines specified in a
purchase order that it has accepted, or specified in its
acceptance of the purchase order, and the failure is
caused by the negligence or willful misconduct of Miza,
then Connetics may require Miza to supply the
undelivered Product at the earliest possible future date
[*] unless otherwise agreed by Connetics, or Connetics
may at its option cancel such portion of the order
without penalty.
3.10 Cancellation of Purchase Orders; Penalties. Connetics may cancel a
purchase order for production in accordance with the provisions in this
Section. The charge for cancellation shall be determined according to
the following schedule:
(a) If Connetics gives at least [*] notice prior to the
manufacturing date assigned by Miza pursuant to SECTION 3.5,
there shall be no penalty for cancellation.
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(b) If Connetics gives [*], Miza may invoice Connetics for, and
Connetics shall be required to pay to Miza an amount equal to
[*] of the amount owed under the purchase order, calculated in
accordance with EXHIBIT B; provided, however, that Miza must use
Commercially Reasonable Efforts to reallocate the suite to
manufacture another product on the originally scheduled date,
and no charge shall be assessed to Connetics if such efforts are
successful.
(c) If Connetics gives [*] Miza may invoice Connetics for, and
Connetics shall be required to pay to Miza an amount equal to
[*] of the amount owed under the purchase order, calculated in
accordance with EXHIBIT B; provided, however, that Miza must use
Commercially Reasonable Efforts to reallocate the suite to
manufacture another product on the originally scheduled date,
and no charge shall be assessed to Connetics if such efforts are
successful.
(d) If Connetics gives [*] of cancellation, Miza may invoice
Connetics for, and Connetics shall be required to pay, an amount
equal to [*] of the amount owed under the purchase order,
calculated in accordance with EXHIBIT B.
3.11 Shipment; Inspection; Rejection
(a) Shipment of Product. Miza shall ship, or cause to be shipped at
Connetics' expense, the Product to Connetics or such
destination(s) as Connetics may designate in writing. Delivery
of Product to a common carrier authorized by Connetics shall
constitute delivery to Connetics, and risk of loss shall pass to
Connetics at that time. Miza agrees to provide support to assist
Connetics to pursue any Product related claims it may have
against carriers, provided that Connetics shall reimburse Miza
for any out-of-pocket expenses Miza may incur in providing such
support. All invoices and other shipping documents shall be sent
by first class mail or by fax to Connetics' address for notices
under this Agreement, directed to the attention of Controller.
(b) Non-Conforming Product. Connetics may reject any batch of
Product that does not conform to the Manufacturing Standards,
subject to the terms of this Section and the Quality Agreement.
Within ten (10) business days after Miza's internal release of
Product, Connetics shall inspect the Product and notify Miza
whether it will accept or reject the Product. No inspection
under this Section shall relieve Miza of its obligations and
warranties under this Agreement. If Connetics rejects all or any
part of any shipment of Product, the procedures to be followed
are:
(i) Connetics shall submit to Miza in writing any claim that
Product does not conform with the Product Specifications
or cGMPs, accompanied by a report of Connetics' analysis
(which analysis
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shall be conducted in good faith) and a sample of the
Product at issue, explaining in reasonable detail the
basis on which the allegedly nonconforming Product does
not meet the Product Specifications. Once nonconformance
is confirmed and fault is determined to belong with Miza
pursuant to the provisions of this Section 3.11(b),
Connetics shall not be obligated to pay for such
nonconforming shipment of Product. Only those tests
listed in the Product Specifications may be used to
demonstrate nonconformance of Product.
(ii) Miza shall conduct its own analysis of the sample in
good faith within thirty (30) days after the receipt by
Miza of the report and sample from Connetics, and
provide the results to Connetics.
(A) If after Miza's own analysis of the sample Miza
agrees with the claim of nonconformity,
Connetics shall promptly inform Miza if
Connetics wishes to have Miza replace the
nonconforming Product with conforming Product.
If Connetics wishes to receive such replacement
Product, Miza shall provide such replacement as
soon as reasonably practicable thereafter, in
which case Connetics shall be obligated to pay
only for such replacement Product. Connetics
shall not be obligated to pay for the
nonconforming Product, and Miza shall: (1)
credit Connetics for the amount paid by
Connetics to Miza for the nonconforming Product
if Connetics has already paid for such
nonconforming Product or (2) cancel its invoice
to Connetics for such nonconforming Product if
Connetics has not yet paid for such
nonconforming Product, and Connetics shall not
be obligated to pay such canceled invoiced
amount.
(B) If, after its own analysis, Miza does not agree
with the claim of nonconformity or determines
that Connetics is responsible for the
nonconformity, such Product shall be tested for
conformance with the applicable Product
Specifications by an independent third party
testing laboratory mutually acceptable to both
parties. The independent analysis shall be
binding on both Parties solely for the purpose
of determining whether such Product may be
rightfully rejected.
(iii) After a final determination that the Product shipment is
nonconforming, and if Miza is responsible for the
nonconformity, Connetics shall return or destroy it at
Miza's request and cost in the most cost effective and
environmentally safe and appropriate
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manner available, consistent with federal, state and
local laws and regulations.
(iv) If conforming Product supplied under this Agreement
becomes nonconforming or unsuitable at no fault of Miza,
Connetics will remain obligated to pay Miza for such
Product. At Miza's request, Connetics shall return such
unsuitable Product to Miza. Otherwise, Connetics shall
destroy it in the most environmentally safe and
appropriate manner available, consistent with federal,
state and local laws and regulations.
(c) Notwithstanding the other provisions of this SECTION 3.11,
Connetics shall have no right to reject any Product that fails
to conform with the Manufacturing Standards if the
nonconformance is attributable to (i) events outside of Miza's
control that occurred after delivery to a common carrier, or
(ii) processes, procedures or Product components specified or
approved in writing by Connetics in the Product Specifications
or otherwise, provided that Miza followed or used such
processes, procedures and Product components materially in
accordance with the Product Specifications.
3.12 Unique Materials. Connetics shall reimburse Miza for its actual costs
expended for the purchase of "Unique Materials" (i.e., certain raw
materials, artwork, printed cans, labels, cartons and special valves)
purchased by Miza expressly to meet its performance obligations under
this Agreement in reliance upon a firm Purchase Order pursuant to
SECTION 3.4 and which later are made obsolete, or to the extent that
such Unique Materials remain on hand at the expiration of this Agreement
as provided under SECTION 10.1. For purposes of this Section, material
is obsolete if it cannot be incorporated into the Product due to changes
mandated by a Regulatory Authority, changes directed by Connetics, or
Connetics-mandated cancellation or postponement. Once material becomes
obsolete, Miza may invoice Connetics for the acquisition costs of such
obsolete material from time to time, which invoices shall identify the
material in question and shall be accompanied by a reasonably detailed
statement of the cause of such obsolescence and a certification that
Miza has disposed of such materials in accordance with the terms of this
Agreement.
3.13 Risk of Loss. Risk of loss of Product shall be with Miza until delivery
of Product to a common carrier pursuant to SECTION 3.11 of this
Agreement. Notwithstanding the forgoing, Miza shall not be liable for
loss of Product caused by an event of force majeure or Connetics'
negligence or willful misconduct.
3.14 Insurance. Miza shall at its own expense obtain and maintain workers'
compensation and comprehensive general liability insurance with respect
to performance under this Agreement, in amounts reasonably determined by
Miza, but in no event less than [*].
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ARTICLE 4
PRICE AND PAYMENT TERMS
4.1 Price for Connetics' Products. Connetics shall pay Miza for Products in
amounts to be agreed for each Product and for each size or formulation.
Effective as of the date first written above, the agreed upon price for
each Product shall be set forth in the document attached as EXHIBIT B to
this Agreement, which Exhibit may be amended from time to time by the
mutual written agreement of the Parties as described in SECTION 4.5,
below.
4.2 Invoices. Miza shall submit to Connetics an invoice five (5) days after
Miza's internal release of Product. Connetics shall make payment of each
invoice within 45 days after receipt by Connetics. If within thirty (30)
days after the delivery of Product and the accompanying Certificate of
Analysis to Connetics, Connetics demonstrates non-conformance under
SECTION 3.11 and Miza agrees with such finding, Connetics shall not be
obligated to pay for such non-conforming shipment.
4.3 Most Favored Vendor. Miza agrees that the price charged to Connetics at
all times during the term of this Agreement shall be Miza's lowest price
for equivalent quantities and lead times, to the extent offered to third
parties in the same marketplace.
4.4 Currency. Amounts due to Miza under this Agreement are payable in U.S.
Dollars.
4.5 Annual Performance and Price Reviews. The Parties agree to review Miza's
performance on each anniversary of this Agreement to determine whether
Miza has complied with its obligations under this Agreement, and to
renew and renegotiate the pricing under this Agreement as appropriate.
If the Parties agree to any changes in the Pricing, a new EXHIBIT B
shall be prepared and made a part of this Agreement by a written
amendment to this Agreement.
ARTICLE 5
WARRANTIES
5.1 Quality. Each shipment of Product under this Agreement shall have been
manufactured in accordance with U.S. cGMPs in a duly licensed facility
and shall have been subject to a quality control inspection by Connetics
in accordance with the Product Specifications and with Connetics' then
current quality control standards and systems. Miza shall number each
Product shipment with a vendor lot number that is traceable to raw
materials and/or components used to manufacture such Product.
5.2 Representations and Warranties.
(a) Miza warrants that Product delivered to Connetics pursuant to
this Agreement shall, at the time of delivery:
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(i) have been manufactured, filled, packaged, stored and
shipped in accordance with all applicable laws, rules,
regulations or requirements;
(ii) have been manufactured, filled, packaged and stored in
accordance with, and will conform to, the Product
Specifications;
(iii) will be free from defects in material, manufacturing and
workmanship for the shelf life of the Product as set
forth in the Product Specifications; and
(iv) not be adulterated or misbranded within the meaning of
the Federal Food, Drug and Cosmetic Act (the "Act") as
amended, or within the meaning of any applicable state
or municipal law in which the definitions of
adulteration and misbranding are substantially the same
as those contained in the Act, as the Act and such laws
are constituted and effective at the time of delivery.
(b) Licensing. Miza represents and warrants that it has obtained and
will maintain on a current basis and will comply with all
licenses, permits and approvals of applicable governmental
agencies as may be required to manufacture, test and store the
Product pursuant to this Agreement and perform its other
obligations under this Agreement. Miza shall be responsible for
obtaining and maintaining licenses and permits for manufacture,
testing and storage of the Product and ensuring that its
facilities used in the manufacture of the Product meet cGMPs in
all respects.
(c) Compliance with Laws. Miza represents and warrants that it shall
comply with all federal, state, local and foreign laws,
regulations and other requirements applicable to the
manufacture, testing and storage of the Product and the
performance of Miza's obligations under this Agreement. Miza
shall have sole responsibility for adopting and enforcing safety
procedures for the handling and manufacture of the Product at
its facilities and the proper handling and proper disposal of
waste relating to the Product.
5.3 Limitations; Indemnification.
(a) Limitations on Warranty. The warranty furnished in SECTION
5.2(B) shall not apply to defects caused by accident or willful
damage, abuse, misuse, neglect, improper testing, handling,
storage or use after delivery by Miza of the Product in question
to Connetics.
(b) No Implied Representations; Warranties or Conditions. EXCEPT AS
OTHERWISE EXPRESSLY PROVIDED IN THIS AGREEMENT, NEITHER MIZA NOR
CONNETICS MAKES ANY REPRESENTATIONS OR WARRANTIES AND THERE ARE
NO CONDITIONS, EXPRESS OR IMPLIED, STATUTORY OR OTHERWISE, WITH
RESPECT TO PRODUCT
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SUPPLIED UNDER THIS AGREEMENT, INCLUDING, WITHOUT LIMITATION,
ANY REPRESENTATIONS, WARRANTIES OR CONDITIONS WITH RESPECT TO
NONINFRINGEMENT, MERCHANTABILITY OR FITNESS FOR A PARTICULAR
PURPOSE OF SUCH PRODUCT, OR ARISING FROM A COURSE OF DEALING OR
USAGE OF TRADE PRACTICE.
(c) Limitation of Liability. EXCEPT FOR ANY LOSS, LIABILITY, DAMAGE
OR OBLIGATION ARISING OUT OF OR RELATING TO THE DISCLOSURE OF
CONFIDENTIAL INFORMATION PURSUANT TO ARTICLE 7 OR AS OTHERWISE
EXPRESSLY SET FORTH IN THIS AGREEMENT, IN NO EVENT SHALL EITHER
PARTY HAVE ANY LIABILITY TO THE OTHER PARTY OR ANY OTHER THIRD
PARTY FOR ANY LOST OPPORTUNITY, COSTS OF PROCUREMENT OF
SUBSTITUTE GOODS OR SERVICES, OR FOR ANY INDIRECT, INCIDENTAL,
CONSEQUENTIAL, PUNITIVE OR SPECIAL DAMAGES ARISING OUT OF THIS
AGREEMENT, UNDER ANY CAUSE OF ACTION OR THEORY OF LIABILITY
(INCLUDING NEGLIGENCE), AND WHETHER OR NOT SUCH PARTY TO THIS
AGREEMENT HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGE.
THESE LIMITATIONS SHALL APPLY NOTWITHSTANDING ANY FAILURE OF
ESSENTIAL PURPOSE OF ANY LIMITED REMEDY. [*].
ARTICLE 6
TECHNOLOGY TRANSFER
6.1 Without derogating from Miza's rights under this Agreement, Miza shall
assist Connetics in qualifying a second source for Product, providing
technical assistance and documentation as necessary, including such
manufacturing technology and know-how so as to permit another entity to
manufacture Product, and Miza agrees to cooperate with Connetics to
facilitate the technology transfer.
6.2 Connetics agrees to reimburse Miza for Miza's expenses in providing the
assistance required in SECTION 6.1 for any second source other than an
Affiliate of Miza.
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ARTICLE 7
CONFIDENTIALITY
7.1 Confidentiality.
(a) Confidential Information. The Parties acknowledge that by reason
of their relationship to each other under this Agreement, each
will have access to certain information and materials concerning
the other's business, plans, trade secrets, customers
(including, but not limited to, customer lists), technology,
and/or products that is confidential and of substantial value to
that Party, which value would be impaired if such information
were disclosed to Third Parties ("CONFIDENTIAL INFORMATION").
Each Party agrees that it will not use in any way other than
expressly authorized or contemplated under this Agreement, nor
disclose to any third party, any such Confidential Information
revealed to it by the other Party (except that Confidential
Information may be disclosed, as required for the purposes of
this Agreement, to any Regulatory Authority, an Affiliate,
assignee, distributor, consultant or third party contractor or
research and development organization under similar written
obligations of non-disclosure and non-use), and will take every
reasonable precaution to protect the confidentiality of such
information and with no less restrictive precautions than it
takes to protect its own confidential information. If
Confidential Information is required to be disclosed in response
to a valid order by a court, Regulatory Authority or other
government body of competent jurisdiction, or if otherwise
required to be disclosed by law, or if necessary to establish
the rights of either Party under this Agreement, the receiving
Party shall use Commercially Reasonable Efforts to provide the
disclosing Party with advance notice of such required disclosure
to give the disclosing Party sufficient time to seek a
protective order or other protective measures, if any are
available, for such Confidential Information.
(b) Exceptions. For purposes of this Agreement, information shall be
deemed Confidential Information if such information, by its
nature or due to the context within which it is disclosed, is
obviously intended by the disclosing Party to be kept
confidential even if not identified as such in writing or with
legends or other markings. The person disclosing Confidential
Information shall endeavor to confirm verbally disclosed
Information as "CONFIDENTIAL" in writing, given the
understanding that failure to do so does not constitute a
designation of non-confidentiality, particularly when the
confidential nature is apparent from context and subject matter.
Upon request by either Party, the other Party will advise
whether or not it considers any particular information or
materials to be Confidential Information. Confidential
Information does not include information, technical data or
know-how that:
(i) is or becomes publicly available through no fault of the
receiving Party or its individual employees, agents or
members amounting to a breach of this Agreement;
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(ii) is lawfully obtained on a non-confidential basis by the
receiving Party from a third party who is not obligated
to retain such information in confidence;
(iii) the receiving Party can demonstrate, by competent
evidence, was known to it or any of its Affiliates from
a source other than the disclosing Party or any of its
Affiliates prior to the disclosure under this Agreement;
(iv) the receiving Party can demonstrate by its written
records is independently developed by employees of the
receiving Party or an Affiliate of the receiving Party,
which employees were neither privy to nor had access to
the Confidential Information and which is developed
without use in any way of the Confidential Information;
(v) must be disclosed to governmental agencies, provided
that: (A) this exception shall only apply to disclosure
to such agencies, and not to any other person or entity;
and (B) the disclosing Party shall (1) provide the other
Party with prompt notice (including copies of all
written requests or demands) of any proposed disclosure
to any governmental agency, with an explanation of the
Confidential Information of the other Party to be
disclosed; and (2) cooperate in any lawful effort by the
other Party to prevent, limit or restrict disclosure of
its Confidential Information to such government agency.
7.2 Remedy. If either Party breaches any of its obligations with respect to
this ARTICLE 7, or if such a breach is likely to occur, the other Party
shall be entitled to seek equitable relief, including specific
performance or an injunction, in addition to any other rights or
remedies, including money damages, provided by law, without posting a
bond.
7.3 Agreement Terms. Subject to SECTION 15.2 and the exclusions set forth in
SECTION 7.1(B), the Parties shall treat the terms and conditions of this
Agreement as Confidential Information; provided, however, after written
notification to the other Party, each Party may disclose the existence
of this Agreement and the material terms and conditions of this
Agreement under circumstances that reasonably ensure the confidentiality
thereof to: (a) any government or regulatory authorities, including
without limitation the United States Security and Exchange Commission
pursuant to applicable law (excluding, to the extent legally permitted,
disclosure of financial terms in any publicly available versions of
information so disclosed), (b) its legal representatives, advisors and
prospective investors, and (c) to Connetics' licensors to the extent
required for compliance with Connetics' obligations under third party
licenses.
7.4 Return of Confidential Information. Within ten (10) days following the
termination of any agreement between the Parties with respect to the
subject matter the receiving Party agrees to promptly return all
tangible items relating to the Confidential Information,
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including all written material, photographs, models, compounds,
compositions and the like made available or supplied by the disclosing
Party to receiving Party, and all copies thereof, upon the request of
the disclosing Party, except such records as may be required to be kept
for FDA or other government regulatory compliance. Recipient further
agrees to identify those persons to whom the Confidential Information
that is the subject of this Agreement was disclosed upon request of the
disclosing Party.
7.5 Inside Information. Miza understands that Confidential Information may
constitute "inside information" of Connetics for securities purposes and
agrees to refrain from any unlawful disclosure, trading or other
improper use of such information.
ARTICLE 8
ASSIGNMENT
8.1 Assumption of CCL Obligations. Miza expressly assumes all obligations of
CCL under the Original Agreement up to the date of this Agreement.
8.2 Assignment by Miza. Miza shall have no right or authority to assign the
Agreement or any portion of the Agreement, to sublet or subcontract in
whole or in part, or otherwise delegate its performance under this
Agreement, without Connetics' prior written consent, which consent shall
not unreasonably be withheld. Notwithstanding the foregoing, nothing in
this Agreement shall prohibit Miza from assigning this Agreement to any
Affiliate of Miza that may from time to time own or operate the facility
at Runcorn, England. No such assignment shall relieve Miza of primary
liability for the performance of its obligations under this Agreement.
8.3 Assignment by Connetics. Connetics may assign this Agreement, provided
prior reasonable written notice has been given to Miza. Miza agrees that
if this Agreement is assigned to any third party or Affiliate, all the
terms and conditions of this Agreement shall obtain between such third
party or Affiliate and Miza with the same force and effect as if said
Agreement had been made with such third party or Affiliate in the first
instance, provided that no such assignment shall relieve Connetics of
primary liability for the due performance of this Agreement.
ARTICLE 9
FORCE MAJEURE
Neither Party shall be considered in default of performance of its obligations
under this Agreement, except any obligation under this Agreement to make
payments when due, to the extent that performance of such obligations is delayed
by contingencies or causes beyond the reasonable control and not caused by the
negligence or willful misconduct of such Party, including but not limited to
strike, fire, flood, earthquake, windstorm, governmental acts or orders or
restrictions, or force majeure, to the extent that the failure to perform is
beyond the reasonable control of the nonperforming Party, if the Party affected
shall give prompt written notice of any such cause to the other Party. The Party
giving such notice shall thereupon be
Page 17
excused from such of its obligations under this Agreement for the period of time
that it is so disabled.
ARTICLE 10
TERM AND TERMINATION
10.1 Term. Subject to the rights to terminate sooner under this Article 10,
this Agreement shall expire on [*] (the "Initial Term"), after which
this Agreement may be renewed for successive periods of one or more
calendar year(s) each, any such agreement to renew to be confirmed in
writing by the Parties. At the end of the Initial Term, this Agreement
shall automatically renew for successive one-year periods under the same
terms and conditions set forth under this Agreement (or such other terms
agreed in writing by the Parties) until terminated in writing in
accordance with the provisions of this Agreement.
10.2 Termination for Material Breach. Either Party may terminate this
Agreement upon written notice if the other Party has breached any of its
material obligations under this Agreement, and (a) such breach has not
been cured within 60 days after written notice of the breach, or (b) if
a plan, reasonably acceptable to the non-breaching Party, is not
implemented to cure as soon as practicable after notice of the breach
10.3 Termination upon Insolvency. Either Party may, in addition to any other
remedies available to it by law or in equity, terminate this Agreement
immediately by written notice to the other Party upon (i) the filing by
the other Party of a voluntary petition in bankruptcy or seeking
reorganization, liquidation, dissolution, winding-up, arrangement,
composition or readjustment of its debts or any other relief under any
bankruptcy, insolvency, reorganization or other similar act or law of
any jurisdiction now or hereafter in effect, (ii) the filing against
such other Party of an involuntary petition in bankruptcy which is not
dismissed within 60 days, (iii) the appointment of a receiver or trustee
of any of such other Party's property if such appointment is not vacated
within 60 days, (iv) the adjudication of such other Party as insolvent,
or (v) the assignment of such other Party's property for the benefit of
its creditors.
10.4 Termination for Force Majeure. Either Party may terminate this Agreement
upon thirty (30) days written prior notice in the event of the other
Party's inability to substantially perform its obligations under this
Agreement for more than one hundred eighty (180) days due to an event of
force majeure as described in SECTION 9.1.
10.5 Termination without Cause. Either Party may terminate this Agreement
upon twelve (12) months' written notice.
10.6 Accrued Liabilities. The termination of this Agreement for any reason
shall not discharge either Party's liability for obligations incurred
under this Agreement and amounts unpaid at the time of such termination.
Connetics shall be liable to pay Miza for any Product, work in progress
and materials purchased by Miza to fulfill its obligations under this
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Agreement, provided however that Miza shall make all Commercially
Reasonable Efforts to mitigate its damages under such circumstances.
10.7 Return and Disposition of Property. Upon the termination of this
Agreement for any reason, each Party shall return to the other Party or
its designee all of such other Party's property, including, but not
limited to, all proprietary information, in its possession. To the
extent required by law or to comply with such Party's continuing
obligations under this Agreement, each Party may keep a single copy of
tangible property belonging to the other Party. Miza shall dispose of
all bulk active ingredients, raw materials, containers, and Labeling not
necessary to complete work in progress at Connetics' expense in
accordance with Connetics' reasonable instructions.
ARTICLE 11
INDEMNIFICATION
11.1 Indemnification by Miza. Miza shall indemnify Connetics, its Affiliates
and their respective directors, officers, employees and agents, and
defend and save each of them harmless, from and against any and all
suits, losses, actions, demands, investigations, claims, damages,
liabilities, costs and expenses (including, without limitation,
reasonable attorneys' fees and expenses) (collectively, "LOSSES")
brought by third parties arising from or occurring as a result of:
(a) a nonconformity of Product with the warranties under SECTIONS
5.1 and 5.2 except for any damages attributable to the
negligence of Connetics, its employees or agents;
(b) Miza's failure to comply with the Product Specifications;
(c) any willful act or omission or negligence of Miza or its
employees, agents or other contractors in the manufacturing and
testing of the Product; or
(d) Miza's failure to comply with the Act and the regulations under
the Act in the production of Product.
(e) any breach (or alleged breach) by Miza of its representations,
warranties, or material obligations under this Agreement;
(f) the manufacture or the storage of the Product prior to the date
of shipment of Product to Connetics by Miza or its Affiliates,
all except to the extent caused by the negligence or willful misconduct
of Connetics or its officers, agents, employees, Affiliates,
sublicensees or customers.
11.2 Indemnification by Connetics. Connetics shall indemnify Miza, its
Affiliates and their respective directors, officers, employees and
agents, and defend and save each of them
Page 19
harmless, from and against any and all Losses brought by third parties
arising from or occurring as a result of:
(a) failure by Connetics to comply with the Food Drug and Cosmetic
Act and the regulations under the Act;
(b) the handling or other use of the Product including by end users;
(c) any willful act or omission or negligence of Connetics or its
employees, agents or other contractors
(d) any breach (or alleged breach) by Connetics of its
representations, warranties, or material obligations under this
Agreement;
(e) the manufacture by Connetics or third parties contracted by
Connetics, or the storage of Product after the date of shipment
of Product to Connetics by Miza or its Affiliates,
all except to the extent caused by the negligence or willful misconduct
of Miza or its officers, agents, employees, Affiliates, sublicensees or
customers.
11.3 Process. If either Party expects to seek indemnification from the other
pursuant to the provisions of this ARTICLE 11, it shall promptly give
notice to the indemnifying Party of any such Claim. The indemnifying
Party shall have the right to control the defense of such Claim and the
indemnified Party shall cooperate with the indemnifying Party in the
defense of such Claim. No settlement or compromise of any Claim shall be
binding on a Party hereto without its prior written consent.
11.4 Patent Indemnification. Connetics shall indemnify and hold Miza and its
employees, servants and agents harmless from and against any and all
claims, demands, actions, suits, losses, damages, costs, expenses
(including reasonable attorney's fees), and liabilities which Miza may
incur, suffer or be required to pay by reason of any patent infringement
suit brought against Miza because of Miza's manufacture of Product to
the extent that the alleged infringement arose out of or related to
Miza's use of processes, compounds or other products the rights to which
are claimed to be owned by Connetics.
ARTICLE 12
AUDIT RIGHTS; INSPECTIONS
12.1 Inspections. Connetics, upon its own discretion and at its own cost and
expense, is entitled during ordinary business hours and at dates
acceptable to Miza to inspect or to have inspected, Miza's plant and
procedures used for manufacture and storage of the Products. Such
inspections shall not materially disrupt Miza's business for other
customers.
Page 20
12.2 Books and Records. Miza agrees to maintain and cause its Affiliates to
maintain complete and accurate books and records of account so as to
enable Connetics to verify amounts due and payable under this Agreement.
In particular, Miza shall preserve and maintain all such records and
accounts required for audit for a period of four (4) years after the
calendar quarter for which the record applies.
12.3 Audit of Miza's Records. During the term of this Agreement, Connetics
shall have the right upon four (4) weeks notice to Miza to have an
independent certified public accountant, selected by Connetics and
reasonably acceptable to Miza, audit Miza's records relating
specifically to the Products during normal business hours; provided,
however, that such audit shall not take place more frequently than once
a year and shall not cover records for more than the preceding four (4)
years.
12.4 Government Inspection. Miza agrees to advise Connetics by telephone and
facsimile immediately of any proposed or announced visit or inspection,
and as soon as possible but in any case within twenty-four (24) hours of
any unannounced visit or inspection, by any Regulatory Authority of any
facilities used by Miza in the performance of its obligations under this
Agreement. Miza shall provide Connetics with a reasonable description of
each such visit or inspection promptly (but in no event later than five
[5] calendar days) thereafter, and with copies of any letters, reports
or other documents (including Form 483's) issued by any such authorities
that relate to the Products, or such facilities, processes or
procedures. Connetics may review Miza's responses to any such reports
and communications, and if practicable, and, insofar as timely received,
Connetics' reasonable views and requests shall be taken into account
prior to submission of such reports and communications to the relevant
Regulatory Authority.
ARTICLE 13
DISPUTES
13.1 Arbitration. If the Parties' are unable to settle amicably any claim,
dispute, controversy or difference arising out of or in relation to or
in connection with this Agreement or for breach of this Agreement
through consultation and negotiation in good faith and a spirit of
mutual cooperation, then the dispute shall be resolved through binding
arbitration in accordance with the rules of the American Arbitration
Association then in effect. Judgment upon the award rendered by the
arbitrators may be entered in any court having jurisdiction thereof. In
any arbitration pursuant to this section, the award shall be rendered by
a majority of the members of a board of arbitration consisting of three
members, one being appointed by each Party and the third being appointed
by mutual agreement of the two arbitrators appointed by the parties. The
place of arbitration shall be [*].
13.2 UN Convention Not Applicable. The Parties expressly disclaim application
to this Agreement of the United Nations Convention on Contracts for the
International Sale of Goods, and agree that it shall not govern or apply
to this Agreement or its performance or construction.
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13.3 Governing Law. This Agreement shall be governed, controlled, interpreted
and defined by and under the laws of [*] and the United States without
regard to that body of law known as conflicts of law; provided that
issues relating to the validity and enforceability of patents shall be
governed by the laws of the jurisdiction by which such patent was
granted.
ARTICLE 14
NOTICES
Any notice required or permitted by this Agreement shall be in writing and shall
be sent by prepaid registered or certified mail, return receipt requested; by
facsimile; by internationally recognized courier; or by personal delivery, in
each case addressed to the other Party at the address below or at such other
address for which such Party gives notice under this Agreement.
Connetics Corporation
Attn: President and Chief Executive Officer
3400 West Bayshore Road
Palo Alto, California 94303
U.S.A.
If to Miza, at:
Miza Pharmaceuticals (UK) Limited
6 Seymour Court, Manor Park
Runcorn, Cheshire, UK
WA7 1SY
Attn: President and CEO
Such notice shall be deemed to have been given when delivered or, if delivery is
not accomplished by some fault of the addressee, when tendered. Either Party may
change its address for notice by delivering a written notice of the new address
in accordance with this Article.
ARTICLE 15
NATURE OF RELATIONSHIP
15.1 No Agency; Independent Contractor. Each Party is and shall be considered
to be an independent contractor of the other Party. Neither Party shall
be the legal agent of the other for any purpose whatsoever and neither
Party has any right or authority to make or underwrite any promise,
warranty or representation, to execute any contract or otherwise to
assume any obligation or responsibility in the name of or on behalf of
the other Party. Neither Party shall be bound by or liable to any third
persons for any act or for any obligation or debt incurred by the other
toward such third party, except to the extent specifically agreed to in
writing by the Party so to be bound.
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15.2 Public Statements. The Parties shall endeavor to provide courtesy copies
of any public announcements concerning the relationship created by this
Agreement. Neither Party shall make any representations concerning the
other without the prior consent from the other Party. Notwithstanding
the foregoing, each Party consents to references to it in reports or
documents or other disclosures sent to stockholders or filed with or
submitted to any governmental authority or stock exchange. Except for
such disclosure as is required by applicable law and/or stock exchange
regulation, neither Party shall make any announcement, news release,
public statement, publication or presentation relating to the existence
of this Agreement or the arrangements referred to in this Agreement
without first notifying the other Party.
ARTICLE 16
ADDITIONAL PROVISIONS
16.1 Headings. Article and section headings contained in this Agreement are
included for convenience of reference only and shall not affect in any
way the meaning or interpretation of this Agreement.
16.2 Partial Invalidity. If any provision of this Agreement is held to be
invalid, illegal, or unenforceable by a court of competent jurisdiction,
then: (a) such provision will be deemed amended to conform to applicable
laws of such jurisdiction so as to be valid and enforceable, or, if it
cannot be so amended without materially altering the intention of the
parties, it will be stricken; (b) the validity, legality and
enforceability of such provision will not in any way be affected or
impaired thereby in any other jurisdiction; and (c) the remaining
provisions of this Agreement will remain in full force and effect.
16.3 Survival. The covenants and agreements set forth in ARTICLES 7, 11 AND
13 shall survive any termination or expiration of this Agreement and
remain in full force and effect regardless of the cause of termination.
16.4 Entire Agreement. This Agreement, including the attached Exhibits,
constitutes the entire agreement of the Parties with respect to the
subject matter, and supersedes all prior or contemporaneous
understandings or agreements, whether written or oral, between Connetics
and Miza with respect to such subject matter. In particular, (a) this
Agreement specifically supercedes and replaces the Original Agreement in
its entirety, and (b) in the event of conflict between this Agreement
and the terms and conditions of any purchase order or other form
generated in performance of this Agreement, then the terms and
conditions of this Agreement shall control, and (c) in the event of
conflict between this Agreement and the Quality Agreement (as it may be
amended from time to time), the terms of this Agreement shall govern all
aspects of the relationship between the Parties except that the Quality
Agreement shall govern with respect to quality matters.
16.5 Waivers. No waiver of any term or condition of this Agreement shall be
valid or binding on either Party unless agreed in writing by the Party
to be charged. The failure of either Party to enforce at any time, or
for any period of time, any provision of
Page 23
this Agreement, or the failure to require at any time performance by the
other Party of any provision of this Agreement, shall in no way be
construed to be a present or future waiver of such provisions or of the
right of such Party thereafter to enforce that provision or other
provisions of this Agreement.
16.6 Assignment, Binding Effect. Neither Party shall assign this Agreement,
by operation of law or otherwise, except to an Affiliate of such Party,
without the prior written consent of the other Party, which consent
shall not be unreasonably withheld, and any such attempted assignment
without such consent shall be void. No assignment shall be effective
until the assignee shall have unconditionally assumed in writing all of
the assignor's obligations under this Agreement and a written notice of
such assignment is given to all the other Parties. When duly assigned in
accordance with the foregoing, this Agreement shall be binding upon and
inure to the benefit of the assignee.
16.7 Amendment. No amendment or modification of this Agreement shall be valid
or binding upon the Parties unless made in writing and signed by the
duly authorized representatives of both Parties.
16.8 Taxes. Miza and Connetics shall cooperate in seeking and/or applying for
all available waivers, exclusions, exemptions, rebates and the like with
respect to potential taxes (e.g., VAT) on the Products.
16.9 Conflicting Terms and Conditions. All sales under this Agreement shall
be subject to the provisions of this Agreement (including, without
limitation, the Product Specifications) and shall not be subject to the
terms and conditions contained on any purchase order of Connetics or
confirmation of Miza, except insofar as any such purchase order or
confirmation establishes:
(a) the quantity and form of any Product ordered;
(b) the shipment date;
(c) the shipment routes and destinations; or
(d) the carrier.
16.10 Binding Effect and Assignment. Each Party agrees that its rights and
obligations under this Agreement may not be transferred or assigned
directly or indirectly, except as follows: (a) either Party may transfer
or assign this Agreement to an Affiliate of such Party which agrees in
writing to undertake the obligations under this Agreement, (b) either
Party may transfer or assign this Agreement in connection with the sale
of all or substantially all of the assigning Party's related business,
and (c) either Party may transfer or assign this Agreement to a
non-Affiliate Third Party with the prior written consent of the other
Party, which consent shall not be unreasonably withheld. Subject to the
foregoing, this Agreement shall be binding upon and inure to, the
benefit of the Parties, their successors and assigns. Any attempted
assignment contrary to the provisions of this SECTION 16.10 shall be
deemed ineffective, and either Party shall have the right to terminate
this Agreement, with the effect described in SECTION 10.2.
Page 24
16.11 Counterparts. This Agreement may be executed in two or more
counterparts, each of which shall be deemed an original and all of which
together shall constitute one and the same agreement.
IN WITNESS WHEREOF, the Parties have caused this Agreement to be duly executed
by their respective duly authorized officers as of the date first written above.
Connetics Corporation Miza Pharmaceuticals (UK) Limited
By: /s/ By: /s/
------------------------------ ----------------------------------
Title: President & CEO Title: President & CEO
-------------------------- ------------------------------
By: /s/
---------------------------------
Title: Executive Vice President
Worldwide Business Development
Page 25
LIST OF EXHIBITS
EXHIBIT A PRODUCTS
EXHIBIT B PRICING
EXHIBIT C QUALITY AGREEMENT
EXHIBIT D FORM OF DEVELOPMENT AGREEMENTS
EXHIBIT A
PRODUCTS
MARKETED NAME NDC CODE SIZE
Luxiq 63032-021-00 100 gram can
Olux 63032-031-00 100 gram can
Luxiq 63032-021-50 50 gram can
Olux 63032-031-50 50 gram can
EXHIBIT B
Pricing
MARKETED NAME SIZE PRICE PER UNIT*
Luxiq 100 gram can [*]
Olux 100 gram can [*]
Luxiq 50 gram can [*]
Olux 50 gram can [*]
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EXHIBIT C
QUALITY AGREEMENT
Quality and Technical Agreement between Connetics Corporation and Miza
Pharmaceuticals (UK) Limited, dated July 26, 2001