Exhibit 10.57
*CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS
DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED
WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
MANUFACTURING AGREEMENT
THIS MANUFACTURING AGREEMENT (the "MANUFACTURING AGREEMENT") is made
effective as of the 31st day of December, 2004 (the "EFFECTIVE DATE") by and
between CELLADON CORPORATION, a California corporation, with its principal place
of business at 2223 Xxxxxxx xx xx Xxxxx, Xxxxx 000, x/x Xxxxxxxxxx Partners
Venture Capital, Xx Xxxxx, XX 00000 ("Celladon"), and TARGETED GENETICS
CORPORATION, a Washington corporation with its principal offices at 0000 Xxxxx
Xxx, Xxxxx 000, Xxxxxxx, Xxxxxxxxxx 00000 ("TGC").
RECITALS
WHEREAS, TGC has developed substantial proprietary technology and is
engaged in the discovery, development and manufacture of viral and non-viral
certain gene-based product candidates and operates a cGMP-compliant production
facility for the manufacture of such candidates;
WHEREAS, concurrently herewith, the parties have entered into a
Collaboration Agreement for the development of cardiac gene therapy products
based partially on Celladon's proprietary technology (the "COLLABORATION
AGREEMENT");
WHEREAS, in connection therewith, the parties wish to enter into this
Manufacturing Agreement pursuant to which TGC will manufacture and supply such
Selected Products to Celladon for use in Phase 1 and Phase 2 human clinical
trials, on the terms and subject to the conditions set forth herein and in the
Collaboration Agreement; and
WHEREAS, Celladon as the Sponsor of certain clinical trials wishes to have
all of its requirements for clinical supply of the Selected Products pursuant to
the Manufacturing Agreement from TGC on an exclusive basis, and TGC wishes to
manufacture and supply to Celladon all of its requirements for the Selected
Product on an exclusive basis, under the terms and conditions set forth herein.
NOW, THEREFORE, in consideration of the foregoing and the mutual promises
and covenants hereinafter set forth, Celladon and TGC, intending to be legally
bound, hereby agree as follows:
ARTICLE 1
DEFINITIONS
Capitalized terms used but not otherwise defined herein shall have
the meanings provided in the Collaboration Agreement. In addition, the following
terms shall have the meanings set forth below:
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1.1 "APPLICABLE LAWS" means all laws, statutes, ordinances, codes, rules
and regulations which have been enacted by a Government Authority and are in
force as of the Effective Date or come into force during the term of this
Manufacturing Agreement, in each case to the extent that the same are applicable
to the performance by the parties of their respective obligations under this
Manufacturing Agreement. For purposes of this Manufacturing Agreement, GLP, GCP
and cGMP shall be deemed to be within the term "Applicable Laws."
1.2 "cGMP" shall mean current good manufacturing practices for medicinal
products established by U.S. laws, rules and regulations (including 21 CFR Parts
210 and 211, as amended, and any successor regulations thereto, each as in
effect from time to time).
1.3 "COLLABORATION AGREEMENT" means the Collaboration Agreement, dated of
even date herewith, by and between TGC and Celladon, and as amended from time to
time.
1.4 "COMMERCIAL AGREEMENT" shall have the meaning set forth in Section
3.2.
1.5 "COMMERCIALLY REASONABLE EFFORTS" shall mean, with respect to the
efforts to be expended by any entity with respect to any objective, reasonable,
diligent, good faith efforts to accomplish such objective as such entity would
normally use to accomplish a similar objective under similar circumstances.
1.6 "DOCUMENTATION" shall mean complete and accurate written documentation
(whether in hard copy or suitable electronic format) of the following
information with respect to the Manufacturing Process: standard operating
procedures that are relevant to the analysis of or the process used to
manufacture Selected Product and quality control of such process; the master
batch records, relevant process development details (in case cGMP product has
not been made), identification of all components and raw materials used in the
manufacture of the Selected Products, diagrams of the TGC facility and equipment
used to manufacture Selected Product, and if contractually permissible,
agreements with Third Party suppliers and subcontractors used by TGC in the
manufacture of Selected Products. For purposes of clarification, the
Documentation need not include documentation of processes or procedures that are
in the public domain and generally known in the pharmaceutical manufacturing
industry.
1.7 "EFFECTIVE DATE" shall have the meaning set forth in the first
paragraph of this Manufacturing Agreement.
1.8 [*] .
1.9 [*] .
1.10 "FFDCA" means the Federal Food, Drug, and Cosmetic Act, 21 U.S.C.
Section 321 et seq., as amended from time to time.
1.11 "GLP" means current good laboratory practices equivalent to those
applicable in the United States and Europe and in effect from time to time
during the term of this Manufacturing Agreement.
*CONFIDENTIAL TREATMENT REQUESTED.
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1.12 "GOVERNMENT AUTHORITY" means any supranational, national, regional,
state or local government, court, governmental agency, authority, board, bureau,
instrumentality or regulatory body.
1.13 "ORDER" means a written description, delivered by Celladon to TGC no
less than nine months in advance of the delivery date specified in the order, as
previously agreed to as part of the Development Plan and accepted or modified by
TGC within thirty days of its receipt, of Selected Product to be supplied for
clinical testing that will cover details of the required preparation including
but not limited to identification of Selected Product, batch number,
concentrations to be prepared, type and number of vials, labeling, and shipping
instructions.
1.14 "OUTSIDE CONTRACTOR" means any Third Party contracted by TGC or
Celladon to provide products or services, including, without limitation,
manufacturing, clinical trials and regulatory services, which are material to
the performance of its responsibilities under the Collaboration Agreement or
which result in any work product or other information that TGC or Celladon would
include or might reasonably be expected to include in any document or report,
including, without limitation, an Approval Application, submitted to a
Government Authority or be subject to review by a Government Authority,
including, without limitation, the FDA. Without limiting the foregoing, the term
"Outside Contractor" shall include any Third Party contracted by TGC or Celladon
whose acts or omissions in connection with its assumption of any obligation of
TGC or Celladon under this Manufacturing Agreement, would be imputed to, and
would therefore be considered the acts or omissions of TGC or Celladon pursuant
to FFDCA or by a Government Authority, including, without limitation, the FDA.
1.15 "PROPRIETARY TECHNOLOGY" shall mean Confidential Information (as
defined in the Collaboration Agreement) of TGC relating to the Manufacturing
Process.
1.16 "STANDARDS AND SPECIFICATIONS" means a list of tests, references to
analytical procedures or methods, investigations, quality release and acceptance
criteria that are numerical limits, ranges, or other criteria for the quality
release of Selected Product which will be defined by TGC and reviewed and
approved by Celladon and modified as required with the written approval of both
parties.
1.17 "TGC COST OF GOODS" shall mean, with respect to any Selected Product
supplied by TGC hereunder:
(A) in the case of bulk or final finished Selected Product
manufactured in whole or in part by TGC, the actual fully allocated cost of
manufacturing such Selected Product (in accordance with cGMP and applicable
Regulatory Approvals) determined in accordance with GAAP consistently applied
throughout the organization of TGC and its Affiliate(s), which includes [*]; and
(B) in the case of Selected Product manufactured entirely by a Third
Party, the [*] by TGC to such Third Party for such Selected Product.
*CONFIDENTIAL TREATMENT REQUESTED.
-3-
1.18 "THIRD PARTY" means any entity or individual other than TGC or
Celladon or their respective Affiliates.
ARTICLE 2
CLINICAL SUPPLY
2.1 SELECTED PRODUCT SUPPLY. TGC shall maintain the Standards and
Specifications and related records by which Selected Product will be
manufactured, filled, packaged, tested, stored and shipped. All Selected Product
Orders shall meet the Standards and Specifications set by TGC and agreed to by
Celladon. TGC shall supply to Celladon, Celladon's total requirements of
Selected Product for use in the clinical trials to be conducted by Celladon
pursuant to Approval Applications, Regulatory Approvals, and the consent of the
Committee. TGC shall manufacture all Selected Product to be supplied by TGC to
Celladon under this Section 2.1. The Development Plan for each year shall set
forth the general quantities, manufacturing schedules, the estimated cost and
the manufacturing pricing to manufacture the Selected Product that will be
necessary to conduct clinical trials that are the subject of Approval
Applications. Lot failures that occur during manufacturing or do not meet the
Standard and Specification will result in a modification of the Development Plan
and Budget to meet the Selected Product needs of the program. TGC will prepare
and package clinical test materials according to the Order for the Selected
Product. TGC shall ensure that adequate samples of each Order are retained and
stored by TGC as reserved quality control samples.
2.2 SELECTED PRODUCT PRODUCTION RECORDS. TGC shall maintain and make
available to Celladon for review, and shall cause its Affiliates, Outside
Contractors and other agents to maintain and make available to Celladon for
review, all records necessary to comply with all Applicable Laws relating to the
manufacture, filling, packaging, testing, storage and shipment of Selected
Product. All such records shall be maintained for such period as may be required
by Applicable Laws; provided, however, that all records relating to the
manufacture, stability and quality control of Selected Product shall be retained
until the Parties agree to dispose of such records.
2.3 SELECTED PRODUCT DELIVERY. The Selected Product will be shipped by TGC
in bulk form or finished form as specified in the Development Plan and Budget
and confirmed in the Order. Prior to each shipment of Selected Product, TGC
shall perform quality control testing and quality assurance review on Selected
Product according to the defined Standards and Specifications. Concurrent with
shipment of the Selected Product, TGC shall deliver to Celladon a final
certificate of testing which describes the compliance of Selected Product with
the defined Standards and Specifications. TGC shall package all items in
suitable containers to permit safe transportation and handling. Each shipped
container will be labeled and marked to identify its contents without having to
be opened, and all boxes and packages must contain packing sheets listing the
contents. Celladon shall bear all transportation, insurance, taxes, duties, and
other costs and risks of loss, spoilage and damage associated with the shipping
and delivery of Selected Products to Celladon or its designated sites.
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2.4 POST TGC INSPECTION. Celladon shall have the right to inspect, analyze
and test samples from each batch of Selected Product for safety parameters and
product identity within fourteen (14) days of its receipt of same in order to
verify that Selected Product conforms to the Product warranties as provided for
in Section 6.1 of this Manufacturing Agreement, provided however, that any
product identity testing, including tests for potency or strength, shall be
conducted by Celladon or a Third Party on its behalf using approved, transferred
and qualified assays of TGC.
2.5 NOTICE OF DEFECTS. Celladon shall promptly, following its inspection
of any Selected Product, notify TGC of any defects therein. If Celladon fails to
inspect, analyze and test samples from any batch of Selected Product or, if it
inspects, analyzes or tests such batch but fails to notify TGC of defects
therein, in each case within [*] days of its receipt of the same, it shall be
deemed to have irrevocably accepted such Selected Product. To the extent that
Celladon notifies TGC of defects in any Selected Product, it shall be deemed to
have irrevocably accepted the Selected Product other than as to those defects
specifically set forth in such notice. For purposes of this Manufacturing
Agreement, Selected Product shall be "defective" or have "defects" only to the
extent that it fails to conform to the warranties set forth in Section 6.1 of
this Manufacturing Agreement. Any notice by Celladon of any defects in a batch
of Selected Product shall specify in reasonable detail how it fails to conform
to any warranty. TGC and Celladon agree to collaborate on any investigation of
defective Selected Product.
2.6 DEFECTIVE SELECTED PRODUCT. Following Celladon's notification to TGC
that a batch of Selected Product is defective, Celladon shall continue to hold
such batch until it receives notice from TGC directing it to do otherwise. If
TGC does not give Celladon notice to ship, continue to hold or dispose of such
batch within [*] days of receipt by TGC of Celladon's notice to TGC of defects
in such batch, Celladon may dispose thereof. If TGC notifies Celladon, within
such [*] day period, to return such batch to TGC, to continue to hold or to
dispose of such batch, Celladon shall comply with such directions from TGC. If
the Selected Product is found to be defective as indicated by Celladon in its
notice to TGC following the conduct of a collaborative investigation by TGC and
Celladon, and the Selected Product is found to be defective due to the gross
negligence of TGC, then TGC shall reimburse Celladon for all reasonable costs
and expenses incurred by Celladon to ship the batch of defective Selected
Product to TGC or to otherwise dispose of such Selected Product.
2.7 NOTICE OF DEFECTS DISPUTE. If TGC does not agree that the Selected
Product, which is the subject of the Notice of Defect, is defective, then
Celladon must provide evidence to the Committee regarding the validity of the
testing performed on the Selected Product. If TGC still does not agree that the
Selected Product is defective then Celladon shall consent to additional testing
by a Third Party agreed upon by the Committee. If the results of the Third Party
testing show that the Selected Product is defective then TGC and Celladon shall
collaborate on an investigation to determine the cause of the defect.
*CONFIDENTIAL TREATMENT REQUESTED.
-5-
2.8 CORRECTION AND REPLACEMENT. If the cause of a Selected Product defect,
following an investigation, is found to be due to the gross negligence of TGC
then TGC may, at its election, replace such batch of Selected Product ,at its
cost, with another batch of identical quantity and a quality that conforms with
the warranties therefor or, if TGC elects to have Celladon return to it any
batch of defective Selected Product, TGC may correct such Selected Product as
may be necessary to ensure that such batch no longer has the defects indicated
in the notice provided by Celladon. If TGC corrects or replaces any batch of
Selected Product, it shall ship such batch as corrected or replaced to Celladon
by a route and carrier of TGC's choice, at TGC's own cost and expense. Title to
and risk of loss of, and damage to, the corrected or replaced batch of Selected
Product shall pass upon delivery thereof to Celladon at the location for
delivery. If as a result of an investigation it is determined by the parties
that the cause of the defect in the Selected Product is not a result of gross
negligence on the part of TGC, then Celladon shall pay for all activities
required to comply with the Order that was the subject of the defective Selected
Product. The appropriate correction or replacement activities necessary to
supply Selected Product to meet the applicable Order will be decided by the
Committee and will be reflected in modifications to the Development Plan and
Budget.
2.9 RECALL. TGC And Celladon agree to collaborate on any recall of
Selected Product supplied by TGC.
2.10 DAMAGES. If TGC receives notice that a batch of Selected Product is
defective and as a result of a collaborative investigation it is determined the
defect is due to the gross negligence of TGC, then if TGC fails to deliver a
corrected or replaced batch of Selected Product, within a period of time agreed
upon by the Committee for delivery of a corrected or replaced batch then, TGC
shall pay the cost of materials and TGC's service for manufacture in lieu of
correcting or replacing such batch. If TGC notifies Celladon in writing that TGC
will pay the cost of manufacture to Celladon with respect to a batch of Selected
Product, TGC shall have no further obligation or liability to Celladon under the
Order pursuant to which such Selected Product was ordered. TGC shall be
obligated to collaborate with Celladon to fill the defective Order by assisting
Celladon's efforts in manufacturing Selected Products by an outside contractor.
2.11 DISTRIBUTION OF SELECTED PRODUCT. Celladon agree to advise TGC of any
clinical studies planned with the Selected Products. No Selected Products
provided by TGC to Celladon shall be supplied or sent by Celladon to any Third
Party, other than those contained in the appropriate Approval Application,
without the unanimous consent of the members of the Committee, except that
Celladon may transfer Selected Product to Celladon's Outside Contractors who are
performing services specified in the applicable Development Plan and Budget,
Order or Approval Application.
-6-
ARTICLE 3
SELECTED PRODUCT MANUFACTURE
3.1 ESTABLISHMENT OF SUPPLY SOURCE. TGC and Celladon agree that TGC will
initially manufacture each Selected Product be at TGC's facilities within the
greater metropolitan area of Seattle, Washington or at such other source as
provide for in this Section 3.1. TGC shall have the right to perform some or all
of its obligations under this Manufacturing Agreement through one or more
Affiliates or Third Party subcontractors, in TGC's discretion; provided,
however, that TGC shall remain responsible for, and be guarantor of, the
performance by all of such Affiliates and Third Party subcontractors and shall
cause its Affiliates and Third Party subcontractors to comply with the
provisions of this Manufacturing Agreement in connection with such performance.
In particular, if any Affiliate or Third Party subcontractor participates in
manufacturing activities under this Manufacturing Agreement, the provisions of
this Manufacturing Agreement that apply to the activities of TGC with respect to
such manufacturing activities shall apply equally to the activities of such
Affiliate or Third Party subcontractor. TGC agrees to provide Celladon advance
written notice of any plans to manufacture Selected Product at non-TGC
facilities or at TGC facilities outside of the greater metropolitan area of
Seattle, Washington.
3.2 COMMERCIAL AGREEMENT. Prior to initiation of Phase 3 clinical trials
of any Selected Product, TGC and Celladon shall enter into a mutually acceptable
Phase 3 Clinical Trials and Commercial Manufacturing Agreement ("COMMERCIAL
AGREEMENT"). In such Commercial Agreement, the parties shall: (i) make
covenants, indemnities and other protections for the benefit of each party, (ii)
make representations and warranties to each other, and (iii) provide for
provisions that are typically contained in agreements to supply
biopharmaceutical materials for Phase 3 clinical studies. In addition, the
Commercial Agreement shall provide that Celladon shall pay to TGC an amount
equal to [*] of the TGC Cost of Goods of such bulk or final finished Selected
Product.
3.3 MANUFACTURING PROCESS EVENTS. TGC shall report in writing to Celladon
any material atypical or out-of-specification event that occurs during the
manufacture or testing of any Selected Product, which event may affect: (i) the
safety, efficacy or regulatory status of such Selected Product, and (ii) when
appropriate, the disposal of any affected Selected Product.
3.4 INSPECTION AND COMPLIANCE.
(A) CELLADON INSPECTION. TGC shall permit Celladon representatives
to enter TGC's facilities upon reasonable prior notice [*] per calendar year,
during normal business hours for the purpose of making a quality assurance audit
of the facilities and of the procedures and processes used by TGC or Outside
Contractors in storing, manufacturing and shipping any Selected Product and to
inspect all related records. To the extent any such inspections, notices,
responses, filings, audits and investigations could lead to the disclosure of
any Proprietary Technology to Celladon: (i) access to such Proprietary
Technology shall be limited to the narrowest practicable group of Celladon's
quality assurance personnel who have a strict need to know the same for the
purposes of such quality assurance inspections, audits and investigations;
*CONFIDENTIAL TREATMENT REQUESTED.
-7-
and (ii) any and all such Proprietary Technology shall be treated as TGC's
proprietary information and shall be protected by Celladon under Section 8 of
the Collaboration Agreement.
(B) TGC INSPECTION. Celladon shall permit representatives of TGC to
enter clinical trial sites upon reasonable prior notice at reasonable intervals,
but no more frequently than [*] per year per site unless a significant adverse
event has been reported to TGC, and with the approval, such approval shall not
be unreasonably withheld or delayed, of the appropriate Celladon medical
director, during normal business hours for the purpose of making quality
assurance audits of the clinical trial sites and of the implementation of the
clinical trial protocol according to the appropriate Regulatory Approval.
(C) SAFETY PROCEDURES. TGC shall maintain and enforce health and
safety procedures for the handling and manufacture of Selected Products that
comply in all respects with all Applicable Laws.
(D) GOVERNMENT INSPECTION. TGC shall provide prompt notice to
Celladon of any inspections or investigations by the FDA or other regulatory
authority directed toward Selected Product or facilities used in the manufacture
of Selected Product, and shall provide Celladon with copies of all
correspondence and reports related to such inspection or investigations as they
become available. Further TGC shall provide prompt notice to Celladon of the
results thereof and any material corrective action TGC was required to take in
order to comply with any Applicable Laws. Celladon's rights hereunder shall
extend to facilities, equipment, record-keeping procedures and records of
Outside Contractors used by TGC with respect to the manufacture of Selected
Product and TGC shall ensure that its agreements with such Outside Contractors
are consistent with this Manufacturing Agreement. To the extent any such
inspections, notices, responses, filings, audits and investigations could lead
to the disclosure of any Proprietary Technology to Celladon: (i) access to such
Proprietary Technology shall be limited to the narrowest practicable group of
Celladon's quality assurance personnel who have a strict need to know the same
for the purposes of such quality assurance inspections, audits and
investigations; and (ii) any and all such Proprietary Technology shall be
treated as TGC's proprietary information and shall be protected by Celladon
under Section 8 of the Collaboration Agreement.
3.5 TGC SUPPLY OBLIGATIONS. If TGC is unable to fulfill its obligations
for Supply of Selected Product under the appropriate Development Plan and Budget
and Order, TGC will promptly notify Celladon of its determination and the
reasons it is unable to do so. Celladon and TGC agree to use Commercially
Reasonable Efforts to arrive at a mutually agreeable resolution.
3.6 FILL AND FINISH OF BULK MANUFACTURED PRODUCT. TGC shall deliver bulk
manufactured Selected Products to the fill/finish Third Party subcontractor
identified by Celladon. TGC may, if agreed upon in the Development Plan or by
mutual agreement of the parties, manage the fill/finish activities required for
bulk manufactured product to be used in clinical trials conducted with Selected
Product supplied under this Manufacturing Agreement. Such management activities
shall be detailed in the applicable Development Plan. TGC shall use such
Commercially Reasonable Efforts to ensure such fill/finish activities are
conducted in accordance with all applicable laws and in compliance with all
procedures that TGC would require for its own products. TGC may choose to
perform fill/finish operations for Selected
*CONFIDENTIAL TREATMENT REQUESTED.
-8-
Products at TGC facilities and with TGC personnel, but TGC has no such
obligation to do so. If TGC chooses to perform fill/finish operations at its
facilities then TGC shall be responsible for the fill/finish operations. If a
batch of product is found to be defective due to fill/finish operations of a
Third Party, TGC's [*] shall be to determine, with Celladon, the appropriate
activities to undertake to replace such batch at the cost of [*] Failure of lots
due to fill/finish operations [*] of the Collaboration Agreement.
ARTICLE 4
PRICES AND PAYMENT
4.1 PRICE. All bulk Selected Product supplied by TGC hereunder for use in
(1) any non-clinical studies necessary to support clinical trials of Selected
Products and (2), clinical trials through Phase 2 that are identified in a
Development Plan, shall be provided at TGC's cost to Celladon and shall be paid
for in accordance with Section 2.4 of the Collaboration Agreement. The parties
acknowledge and agree that TGC shall be responsible for all payments to its
Affiliates and to Third Parties for any materials purchased from, or other
products or services provided by, such Affiliates and Third Parties in
connection with the manufacture and packaging of bulk Selected Product
hereunder, except as specified in Section 2.4 of the Collaboration Agreement or
unless otherwise mutually agreed by the Parties. For Selected Product supplied
by TGC under the Commercial Agreement, Celladon shall pay to TGC an amount equal
to 125% of the TGC Cost of Goods of such bulk or final finished Selected
Product.
ARTICLE 5
TECHNOLOGY [*]
5.1 ACKNOWLEDGMENTS. Celladon acknowledges that TGC considers the
Manufacturing Process and related information to be its valuable confidential
and proprietary information and that TGC desires to avoid disclosure of same
except under certain very limited circumstances described below in this Article
5. TGC acknowledges that the availability of such information is critical to
Celladon in the conduct of its business and that Celladon will require access to
the Documentation under certain limited circumstances described below in this
Article 5. Accordingly, TGC and Celladon desire [*] to provide for [*]
Celladon's controlled access to, the Documentation. The parties desire this
Agreement to be supplementary to the Collaboration Agreement pursuant to Section
365(n) of the U.S. Bankruptcy Code.
5.2 TECHNOLOGY [*]. Within 90 days from the Effective Date, the parties
shall [*] shall include a detailed itemization of the Documentation. [*] TGC
shall [*] the Documentation [*] no later than 30 days following delivery of the
first batch of Selected Product to Celladon; provided, however, that if [*]
shall be made as soon as practicable after completion of TGC's quality assurance
audit and approval of Documentation following delivery of the first batch of
Selected Product to Celladon. TGC shall update the Documentation every six
months thereafter during the term of this Agreement, within 30 days of the end
of each six-month period, to include all additional or revised Documentation as
is necessary to make the Documentation complete as of such date. All such
updated [*] shall be subject to the provisions of this Article 5
*CONFIDENTIAL TREATMENT REQUESTED.
-9-
to the same extent [*], and all references in this Agreement to the
Documentation shall include the initial Documentation and any updates thereto.
Prior to the delivery of any Documentation [*], TGC shall conspicuously label
for identification each document, magnetic tape, disk, or other media upon which
the Documentation is written or stored. All Documentation required [*] hereunder
shall be delivered by TGC [*] in a manner that is readable and usable in its
current form or, if any portion of the Documentation is encrypted, the
decryption tools and decryption keys shall have also [*] by TGC [*] concurrently
with such Documentation.
5.3 [*] DOCUMENTATION. The parties agree[*] the Documentation to Celladon
or its designee upon notification by Celladon [*] that the Collaboration
Agreement has terminated automatically pursuant to Section 9.4 thereof, or the
Collaboration Agreement has been terminated by Celladon pursuant to Section
9.2(a) thereof. [*] commercially reasonable provisions regarding resolution of
disputes as to whether the conditions [*] of the Documentation to Celladon have
been satisfied.
5.4 RIGHT TO USE [*]. Upon [*], Celladon shall have the right to use the
Documentation solely for the purpose of exercising and fully exploiting the
licenses granted to it by TGC under the Collaboration Agreement. Celladon shall
be obligated to maintain the confidentiality of the [*] Documentation in
accordance with the confidentiality provisions set forth in the Collaboration
Agreement.
ARTICLE 6
REPRESENTATIONS, WARRANTIES AND COVENANTS
6.1 REPRESENTATIONS AND WARRANTIES OF TGC CONCERNING MANUFACTURE AND
SUPPLY. TGC represents and warrants that, at the time of shipment of any
Selected Product to Celladon, such Selected Product (i) will have been
manufactured, filled, packaged, stored and shipped in accordance with applicable
Regulatory Approvals and all Applicable Laws, (ii) will be manufactured and
supplied in accordance with cGMP, the Standards and Specifications for the
Selected Product and the requirements of the Order and (ii) will not be
adulterated or misbranded under the FFDCA, or under any other Applicable Laws.
TGC further represents and warrants that it shall obtain and maintain, and use
Commercially Reasonable Efforts to cause its Affiliates and Outside Contractors
to: (i) obtain and maintain, all necessary licenses, permits or approvals
required by Applicable Laws in connection with the manufacture, filling,
packaging, testing, and storage, of each such Selected Product, including,
without limitation, permits related to manufacturing facilities, and (ii) meet
all Standards and Specifications set for the Selected Product in the Order.
EXCEPT AS EXPRESSLY SET FORTH IN THIS PARAGRAPH OR IN THE COLLABORATION
AGREEMENT, TGC MAKES NO REPRESENTATIONS OR WARRANTIES OF ANY KIND WHATSOEVER,
EITHER EXPRESS OR IMPLIED, WRITTEN OR ORAL, INCLUDING, WITHOUT LIMITATION ANY
IMPLIED WARRANTY OF MERCHANTABILITY, WARRANTY OF FITNESS FOR A PARTICULAR
PURPOSE, OR WARRANTY OF NON-INFRINGEMENT.
*CONFIDENTIAL TREATMENT REQUESTED.
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ARTICLE 7
CLINICAL TRIAL INDEMNIFICATION; LIMITATION OF LIABILITY
7.1 CLINICAL TRIAL INDEMNIFICATION BY CELLADON. Solely with respect to
activities contemplated by this Manufacturing Agreement, Celladon hereby agrees
to save, defend, and hold TGC, its Affiliates and their officers, directors,
employees and agents (the "TGC INDEMNITEES") harmless from and against any and
all losses, damages, liabilities, costs and expenses, including reasonable
attorneys' fees and expenses (collectively, "LOSSES") to which any TGC
Indemnitee may become subject as a result of any claim, demand, action or other
proceeding by any Third Party, to the extent such Losses result from or arise
out of: (i) the storage of Selected Product or the conversion of Selected
Product from bulk to finished form, in each case after the shipping of such
Selected Product to Celladon; or (ii) the conduct of clinical trials of Selected
Products by Celladon, its Affiliates or licensees (in regard to (i) and (ii),
except to the extent caused by the negligence or willful misconduct of, or
failure to comply with Applicable Laws or breach of this Manufacturing Agreement
by, TGC or its Affiliates, Outside Contractors and its or their directors,
officers, agents, employees or consultants or clinical investigators, and except
to the extent such Losses result from or arise out of any act or omission for
which TGC is found to have an indemnification obligation pursuant to Section 7.2
of this Manufacturing Agreement); or (iii) the negligence or willful misconduct
of Celladon or its Affiliates, licensees (excluding TGC) or sublicensees, and
its or their directors, officers, agents, employees, or consultants or clinical
investigators; or (iv) the material breach by Celladon of any representation,
warranty, covenant or other provision of this Manufacturing Agreement.
7.2 CLINICAL INDEMNIFICATION BY TGC. Solely with respect to activities
contemplated by this Manufacturing Agreement, TGC hereby agrees to save, defend
and hold Celladon, its Affiliates and their officers, directors, employees and
agents (the "CELLADON INDEMNITEES") harmless from and against any and all Losses
to which any Celladon Indemnitee may become subject as a result of any claim,
demand, action or other proceeding by any Third Party, to the extent such Losses
result from or arise out of: (i) the manufacture of Selected Product, the use of
a Selected Product in a clinical trial in strict compliance with the protocol
for such trial, or the storage of Selected Product prior to the date of delivery
thereof to Celladon (except to the extent caused by the negligence or willful
misconduct of, or failure to comply with Applicable Laws or breach of terms of
this Manufacturing Agreement by, Celladon or its Affiliates, licensees or
sublicensees (other than TGC), and its or their directors, officers, agents,
employees, consultants or clinical investigators); or (ii) the negligence or
willful misconduct of TGC, or its Affiliates, Outside Contractors, and its or
their directors, officers, agents, employees or consultants; or (iii) the
material breach by TGC of any representation, warranty, covenant or other
provision of this Manufacturing Agreement (including, without limitation,
Section 6.1 hereof). For the purposes of this section, deviations from the terms
of a protocol that may arise out of medical necessity do not constitute
negligence, error, omission or malfeasance provided that Celladon confirm in
writing the fact of and provide reasonable details of any such deviation within
a reasonable time thereafter.
7.3 CLINICAL INDEMNIFICATION PROCEDURE. This Section 7.3 shall apply
solely with respect to indemnification contemplated under the Manufacturing
Agreement.
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(A) Each indemnified party (the "Clinical Indemnitee") agrees to
give the indemnifying party (the "Clinical Indemnitor") prompt written notice of
any Losses or discovery of fact upon which the Clinical Indemnitee intends to
base a request for indemnification. Notwithstanding the foregoing, the failure
to give timely notice to the Clinical Indemnitor shall not release the Clinical
Indemnitor from any liability to the Indemnitee to the extent the Clinical
Indemnitor is not prejudiced thereby.
(B) The Clinical Indemnitee shall furnish promptly to the Clinical
Indemnitor copies of all papers and official documents in the Clinical
Indemnitee's possession or control which relate to any Losses; provided,
however, that if the Clinical Indemnitee defends or participates in the defense
of any Losses, then the Clinical Indemnitor shall also provide such papers and
documents to the Clinical Indemnitee. The Clinical Indemnitee shall cooperate
with the Clinical Indemnitor in providing witnesses and records necessary in the
defense against any Losses.
(C) The Clinical Indemnitor shall have the right, by prompt notice
to the Clinical Indemnitee, to assume direction and control of the defense of
any Third Party claim forming the basis of such Losses, with counsel reasonably
acceptable to the Clinical Indemnitee and at the sole cost of the Clinical
Indemnitor, so long as (i) the Clinical Indemnitor shall promptly notify the
Clinical Indemnitee in writing (but in no event more than thirty (30) days after
the Clinical Indemnitor's receipt of notice of the claim) that the Clinical
Indemnitor intends to indemnify the Clinical Indemnitee from and against any
Losses the Clinical Indemnitee may suffer arising out of the claim absent the
development of facts that give the Clinical Indemnitor the right to claim
indemnification from the Clinical Indemnitee and (ii) the Clinical Indemnitor
diligently pursues the defense of the claim.
(D) If the Clinical Indemnitor assumes the defense of the claim as
provided in Section 7.3(c) above or Section 7.3(e) below the Clinical Indemnitee
may participate in such defense with the Clinical Indemnitee's own counsel who
shall be retained, at the Clinical Indemnitee's sole cost and expense; provided,
however, that neither the Clinical Indemnitee nor the Clinical Indemnitor shall
consent to the entry of any judgment or enter into any settlement with respect
to the claim without the prior written consent of the other party, which consent
shall not be unreasonably withheld or delayed. If the Clinical Indemnitee
withholds consent in respect of a judgment or settlement involving only the
payment of money by the Clinical Indemnitor and which would not involve any
stipulation or admission of liability or result in the Clinical Indemnitee
becoming subject to injunctive relief or other relief, the Clinical Indemnitor
shall have the right, upon notice to the Clinical Indemnitee within five (5)
days of receipt of the Clinical Indemnitee's written denial of consent, to pay
to the Clinical Indemnitee, or to a trust for its or the Third Party's benefit,
as shall be established at trial or by settlement, the full amount of the
Clinical Indemnitor's obligation under Section 7.1 or Section 7.2, as
applicable, with respect to such proposed judgment or settlement, including all
interest, costs or other charges relating thereto, together with all attorneys'
fees and expenses incurred to such date for which the Clinical Indemnitor is
obligated under this Manufacturing Agreement, if any, at which time the Clinical
Indemnitor's rights and obligations with respect to the claim shall cease.
(E) If the Clinical Indemnitor does not so assume the defense of
such claim, the Clinical Indemnitee may conduct such defense with counsel of
the Clinical Indemnitee's
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choice but may not settle such case without the written consent of the Clinical
Indemnitor, such consent not to be unreasonably withheld or delayed. In
addition, the Clinical Indemnitor shall have the right to assume control of the
defense, at its own expense, at any time upon five (5) days' prior notice to the
Clinical Indemnitee.
(F) Except as provided in Section 7.3(e) above, the Clinical
Indemnitor shall not be liable for any settlement or other disposition of a Loss
by the Clinical Indemnitee which is reached without the written consent of the
Clinical Indemnitor.
(G) Except as otherwise provided in this Section 7.3, the portion of
costs and expenses, including reasonable fees and expenses of counsel, incurred
by any Clinical Indemnitee under Section 7.3(e) in connection with any claim
corresponding to the Clinical Indemnitor's obligation under Section 7.1 or
Section 7.2, as applicable, shall be reimbursed on a calendar quarter basis by
the Clinical Indemnitor, for so long as the Clinical Indemnitee controls the
defense of the claim, without prejudice to the Clinical Indemnitor's right to
contest the Clinical Indemnitee's right to indemnification and subject to refund
in the event the Clinical Indemnitor is ultimately held not to be obligated to
indemnify the Clinical Indemnitee.
7.4 LIMITATION OF LIABILITY; REMEDIES CUMULATIVE.
(A) EXCEPT FOR EACH PARTY'S INDEMNIFICATION OBLIGATIONS HEREUNDER
AND ANY CLAIMS RELATED TO ONE PARTY'S INFRINGEMENT OF THE OTHER PARTY'S
INTELLECTUAL PROPERTY OUTSIDE OF THE RIGHTS AND LICENSES GRANTED HEREUNDER OR
BREACH BY A PARTY OF ITS CONFIDENTIALITY OBLIGATIONS HEREUNDER, UNDER NO
CIRCUMSTANCES SHALL A PARTY HERETO BE LIABLE TO THE OTHER PARTY HERETO FOR
CONSEQUENTIAL, INCIDENTAL, PUNITIVE OR SPECIAL DAMAGES.
(B) THE REMEDIES PROVIDED IN THIS MANUFACTURING AGREEMENT ARE
CUMULATIVE AND NOT EXCLUSIVE OR IN LIMITATION OF ANY OTHER REMEDY AVAILABLE
UNDER THIS MANUFACTURING AGREEMENT OR AT LAW OR IN EQUITY. ACCORDINGLY, UNLESS
OTHERWISE EXPRESSLY PROVIDED IN THIS MANUFACTURING AGREEMENT, A REMEDY PROVIDED
IN THIS MANUFACTURING AGREEMENT AS AVAILABLE EITHER TO TGC OR CELLADON IS NOT
INTENDED AS AN EXCLUSIVE REMEDY.
ARTICLE 8
INTELLECTUAL PROPERTY
Unless specifically and expressly granted herein, no licenses or rights under
either Party's intellectual property rights are implied or granted in this
Manufacturing Agreement. The prosecution of any patents, patent applications and
any and all other intellectual property rights associated with the manufacture
and supply of Gene Therapy Products shall be governed by the terms of the
Collaboration Agreement.
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ARTICLE 9
TERM AND TERMINATION
The term of this Manufacturing Agreement shall commence as of the
Effective Date and continue until the earlier of: (i) execution by the parties
of the Commercial Agreement, or (ii) the expiration or termination of the
Collaboration Agreement.
ARTICLE 10
MISCELLANEOUS
10.1 OTHER TERMS AND CONDITIONS. Each party agrees that all other terms
and conditions of the Collaboration Agreement that are not inconsistent with the
Manufacturing Agreement shall have the same effect as if they were included as
part of the Manufacturing Agreement.
10.2 FURTHER ACTIONS. Each party agrees to execute, acknowledge and
deliver such further instruments, and to do all such other acts, as may be
necessary or appropriate in order to carry out the purposes and intent of this
Manufacturing Agreement. If any of the provisions of this Manufacturing
Agreement are in conflict with any agreement for clinical services that Celladon
has with a Third Party, TGC and Celladon will work together to resolve any
disputes or conflict with any such clinical trial site agreement.
10.3 GOVERNMENTAL APPROVALS; COMPLIANCE WITH LAW. The Parties shall make
all filings with Government Authorities as shall be required by Applicable Laws
in connection with this Manufacturing Agreement and the activities contemplated
hereunder or thereunder. In fulfilling its obligations under this Manufacturing
Agreement each party agrees to comply in all material respects with all
Applicable Laws.
10.4 NOTICES. All Selected Product quality notices sent to Celladon shall
be addressed to:
CELLADON CORPORATION
2223 Xxxxxxx xx xx Xxxxx, Xxxxx 000
x/x Xxxxxxxxxx Partners Venture Capital
Xx Xxxxx, XX 00000
Attention: Xxxx Xxxx
FAX: (000) 000-0000
All Selected Product quality notices sent to TGC shall be addressed to:
Targeted Genetics Corporation
0000 Xxxxx Xxx, Xxxxx 000
Xxxxxxx, XX 00000
Attention: Xxx Xxxxxxxxxx
xxxxxxxx@xxxxxx.xxx
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FAX: 000-000-0000
All Orders shall be sent by an authorized representative of Celladon to
TGC shall be addressed to:
Targeted Genetics Corporation
0000 Xxxxx Xxx, Xxxxx 000
Xxxxxxx, XX 00000
Attention: Chief Executive Officer
FAX: 000-000-0000
10.5 ENTIRE AGREEMENT. This Manufacturing Agreement, an Order and the
Collaboration Agreement, including all schedules and exhibits attached thereto,
which are hereby incorporated herein and therein by reference, set forth all
covenants, promises, agreements, warranties, representations, conditions and
understandings between the Parties hereto and supersedes and terminates all
prior and contemporaneous agreements and understandings between the Parties.
There are no covenants, promises, agreements, warranties, representations,
conditions or understandings, either oral or written, between the Parties other
than as set forth herein or therein. No subsequent alteration, amendment, change
or addition to this Manufacturing Agreement shall be binding upon the Parties
hereto unless reduced to writing and signed by the respective authorized
officers of the Parties.
10.6 GOVERNING LAW. This Manufacturing Agreement shall be governed by, and
construed and enforced in accordance with, the laws of the State of California,
excluding its conflicts of laws principles.
10.7 COUNTERPARTS. This Manufacturing Agreement may be executed in
counterparts, each of which shall be deemed an original, but all of which
together shall constitute one and the same instrument.
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IN WITNESS WHEREOF, the Parties have executed this Manufacturing Agreement
by their proper officers as of the date and year first above written.
CELLADON CORPORATION
By: /s/ Xxxx Xxxx
----------------------------------
Print Name:
--------------------------
Its:
---------------------------------
TARGETED GENETICS CORPORATION
By: /s/ H. Xxxxxxx Xxxxxx
----------------------------------
Print Name: H. Xxxxxxx Xxxxxx
--------------------------
Its: CEO
---------------------------------
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