MANUFACTURING AGREEMENT FOR CLINICAL TRIAL AND COMMERCIAL SUPPLY

**

Confidential provision omitted and filed separately with the Securities and Exchange Commission (“SEC”), based upon a request for confidential treatment filed with the SEC.

1.

DEFINITIONS

1.1

AFFILIATE means any entity that directly or indirectly owns, is owned by, or is under common ownership with, Corautus or BI Austria, where “own” or “ownership” means possession or control of at least 50% of the voting capital shares or voting rights of a corporation or a comparable equity interest in any other type of entity.

1.2

AGENT means any person who is not an employee of either PARTY and who renders services for one of the PARTIES in the field of the manufacture, testing, use or sale of the DRUG PRODUCT. Use of an AGENT by a PARTY requires the other PARTY’s prior consent in writing, such consent not to be unreasonably withheld. The AGENT consented to shall enter into a separate confidentiality agreement with the other PARTY.

1.3

AGREEMENT means this Manufacturing AGREEMENT for Clinical Trial and Commercial Supply.

1.4

BATCH RECORD means the complete written record of the history of the batch and its production thereof as required under GMP and in accordance with the MASTER BATCH RECORD.

1.5

BLA means the Biologics License Application for DRUG PRODUCT.

1.6

CMC means the chemistry, manufacturing and controls content of a submission for registration to HEALTH AUTHORITIES.

1.7

COA means the Certificate of Analysis prepared for the DRUG SUBSTANCE or DRUG PRODUCT as applicable, listing the analytical test performed, the limits and results of each test. This document shall include the name of the DRUG SUBSTANCE or DRUG PRODUCT as applicable, the batch number, the date of manufacture and the expiry date, if appropriate.

1.8

COC means the Certificate of Compliance prepared for the DRUG SUBSTANCE or DRUG PRODUCT as applicable confirming compliance with GMP regulations and signed by BI Austria’s Qualified Person and Quality Management which terms are defined in the QUALITY AGREEMENT.

1.9

CONFIDENTIAL INFORMATION means any information disclosed by a PARTY or an AFFILIATE or AGENT of such PARTY to the other PARTY, its AFFILIATE or AGENT, which information includes, but is not limited to: DRUG PRODUCT; the processes and methods employed in the manufacture of DRUG PRODUCT; BATCH RECORDS, SPECIFICATIONS; information related to the facilities at BI Austria; information related to plasmid production processes or to any products produced at the BI Austria facilities; any prices and costs of BI Austria; regulatory filings for the DRUG PRODUCT; Corautus’ and BI Austria’s manufacturing, business and regulatory plans and strategies; and other data and information disclosed or exchanged under this AGREEMENT. Any INVENTION of a PARTY as set forth in Section 1.26 shall also be regarded as CONFIDENTIAL INFORMATION of such PARTY.

1.10

CONFIRMATORY BATCHES means the two (2) ** working volume fermentation batches and small scale purification batches pursuant to Section 6.3.2, which have been completed.

1.11

CONFORMANCE BATCHES means three (3) batches to carry out the process validation and which will form part of regulatory submissions.

1.12

CORAUTUS WCB means the GMP working cell bank of viable E. coli containing the original plasmid construct pVGI.1(VEGF2) as prepared by Corautus, described in Exhibit 1 and provided to BI Austria by Corautus.

1.13

DATE AVAILABLE FOR DELIVERY means the date on which Corautus requests that DRUG PRODUCT be available for shipment.

1.14

DRUG SUBSTANCE means bulk of the vascular endothelial growth factor-2 gene referred to as VEGF-2 and proprietary naked plasmid DNA encoding for VEGF-2, including the plasmid DNA sometimes referred to as phVEGF-2 or pVGl.1(VEGF2) as defined in Exhibit 2 and produced using the SELECTED WCB and BI Austria’s proprietary production process.

1.15

DRUG SUBSTANCE SPECIFICATIONS means the testing SPECIFICATIONS which are attached in Exhibit 3, and mutually amended from time to time by the PARTIES in accordance with Change Control, as defined in the Quality AGREEMENT.

1.16

DRUG PRODUCT means a finished product consisting of formulated DRUG SUBSTANCE filled into designated containers, as described in Exhibit 4, or shall mean a finished product of formulation buffer filled into the designated containers (placebo).

1.17

DRUG PRODUCT SPECIFICATIONS means the testing SPECIFICATIONS for DRUG PRODUCT as set forth in Exhibit 5, as may be revised from time to time by the PARTIES in accordance with Change Control.

1.18

EMEA means the European Agency for the Evaluation of Medicinal Products and any successor agency or entity having similar jurisdiction.

**

Confidential provision omitted and filed separately with the Securities and Exchange Commission (“SEC”), based upon a request for confidential treatment filed with the SEC.

1.19

FDA means the United States Food and Drug Administration or any successor agency having similar jurisdiction.

1.20

FEASIBILITY STUDY means the feasibility study as set forth in Exhibit 6 in order to select an E. coli host and fermentation process mode for the manufacture of DRUG SUBSTANCE.

1.21

FINAL RELEASE means the release of DRUG PRODUCT by Corautus for use in clinical trials or for commercial use in accordance with Corautus’ standard operating procedures. Final Release signifies that the DRUG PRODUCT has been produced using approved processes, in compliance with appropriate regulations, and meets the established SPECIFICATIONS, as determined by Corautus’ review of all appropriate documentation.

1.22

GMP means current Good Manufacturing Practices pursuant to (a) EEC Directive 91/356/EEC of 13 June 1991, (b) the EC Guide to Good Manufacturing Practice for Medicinal Products (c) the U.S. Federal Food, Drug and Cosmetics Act as amended (21 USC 301 et seq .), (d) relevant U.S. regulations set forth in Title 21 of the U.S. Code of Federal Regulations (including Parts 11, 210, and 211), and (f) any applicable European and/or U.S. laws, regulations or respective guidance documents subsequently established.

1.23

HEALTH AUTHORITIES mean all regulatory authorities having jurisdiction over the manufacture, use and/or sale of the DRUG PRODUCT in the TERRITORY, including but not limited to the EMEA or the FDA.

1.24

IMPLEMENTATION BATCHES mean the two (2) BATCHES of DRUG SUBSTANCE and/or DRUG PRODUCT to technically implement the production process into the BI Austria GMP plant.

1.25

INTELLECTUAL PROPERTY means patents, trade secrets, trade marks, service marks, registered designs, lab notebooks, applications for any of the foregoing, trade and business names, unregistered trade marks and service marks, copyrights, rights in designs, inventions, know-how, rights under licenses, consents, orders, statutes or otherwise in relation to any such rights, and rights of the same or similar effect or nature, in any part of the world.

1.26

INVENTION shall mean any invention, discovery or know-how, whether patentable or not, made or conceived by either PARTY, arising as a direct result of work performed under this AGREEMENT.

1.27

MANUFACTURER RELEASE means BI Austria’s release of a batch.

1.28

MASTER BATCH RECORD means the master production instructions for manufacture of a batch.

1.29

MCB means Corautus GMP Master Cell Bank.

1.30

METHOD TRANSFER SERVICES mean services provided by BI Austria in accordance with Section 6.4.

1.31

PARTY and PARTIES means Corautus or BI Austria, or both, as applicable.

1.32

PERIOD ONE means the period of time commencing when any Services are first performed under this AGREEMENT and ending at the completion of the IMPLEMENTATION BATCHES.

1.33

PERIOD TWO means the period of time commencing with the GMP production of the reference standard and ending at the completion of the CONFORMANCE BATCHES.

1.34

PERIOD THREE means the period of time commencing after the completion of the CONFORMANCE BATCHES through the termination of this AGREEMENT.

1.35

PURCHASE ORDER means a written and signed notice provided by Corautus stating the required amount of DRUG PRODUCT (which amount must be within the purchasing obligation of Corautus as given in the Red Zone of the then current Rolling Forecast) including date and address of delivery, the invoicing address, and contact details of persons to be notified in the event of shipment issues.

1.36

QUALITY AGREEMENT means the agreement on all quality procedures, aspects and responsibilities of the PARTIES related to the DRUG PRODUCT, a copy of which is attached as Exhibit 25 to this AGREEMENT.

1.37

SELECTED WCB means the GMP working cell bank manufactured from the E. coli host cell selected as result of the FEASIBILITY STUDY; such SELECTED WCB shall contain the E. coli host cell (with the plasmid incorporated therein) and used for manufacture of the DRUG PRODUCT.

1.38

SERVICES mean the services to be performed by BI Austria in connection with the process establishment and manufacture of the DRUG PRODUCT, and preparing BI Austria to be approved by the HEALTH AUTHORITIES as a GMP manufacturer of DRUG PRODUCT, as further described in Exhibit 7.

1.39

SOPs mean written standard operating procedures established, or to be established, by BI Austria and employed in the production, quality control, quality assurance, warehousing, labeling and packaging, among other things.

1.40

SPECIFICATIONS mean numerical limits, ranges or other acceptance criteria for which the raw materials, DRUG SUBSTANCE, DRUG PRODUCT, intermediates, or the process of making the DRUG PRODUCT, must conform to in order for the DRUG PRODUCT to be acceptable for its intended use.

1.41

STABILITY STUDIES mean all studies necessary to assess the stability characteristics of intermediates, DRUG SUBSTANCE or DRUG PRODUCT which shall be used in determining appropriate storage conditions and expiration dates.

1.42

TERRITORY means the United States and Europe. Countries to be defined as Europe are listed on Exhibit 8.

1.43

TESTING SPECIFICATIONS means a specific master document that lists the testing parameters, references to analytical procedures and their SPECIFICATIONS; types of TESTING SPECIFICATIONS include but are not limited to the WCB, in-process controls, DRUG SUBSTANCE, DRUG PRODUCT and raw materials.

1.44

VALIDATION means documented evidence which provides a high degree of assurance that a specific process, activity, piece of equipment, SOP or other consumable required or used in the manufacture of DRUG PRODUCT will consistently meet its pre-determined and expected results.

1.45

VALIDATION SERVICES means any VALIDATION services required of BI Austria in the manufacture of DRUG PRODUCT.

2.

PURPOSE AND SCOPE

2.1

This AGREEMENT is intended to provide the structure under which the long-term clinical and/or commercial manufacturing of DRUG PRODUCT shall be performed for Corautus by BI Austria. The SERVICES and commercial manufacturing will be performed in three time periods: PERIOD ONE, PERIOD TWO and PERIOD THREE.

2.2

Corautus desires BI Austria to apply BI Austria’s independently developed proprietary manufacturing technology for the manufacture of DRUG SUBSTANCE at BI Austria’s GMP facilities in Vienna, Austria. BI Austria has performed a FEASIBILITY STUDY in order to select an E. coli host and fermentation process mode for the manufacture of DRUG SUBSTANCE. The PARTIES assume that the WCB for the manufacture of DRUG SUBSTANCE is compatible to BI Austria’s production process, and that fermentation is scaleable to 220 L working volume. BI Austria’s patent estate with respect to BI Austria’s manufacturing technology is set forth in Exhibit 9.

2.3

Corautus physically possesses and owns or licenses all ownership rights to the respective GMP MCB and CORAUTUS WCB provided by Corautus to BI Austria. Corautus’ patent estate with respect to the GMP WCB, the DRUG SUBSTANCE and the DRUG PRODUCT which is relevant to this AGREEMENT is referenced in Exhibit 10.

2.4

The DRUG SUBSTANCE was previously produced by HGS for Corautus at a 750 L scale with a fermentation expression rate of about 30 mg DRUG SUBSTANCE per liter fermentation broth.

2.5

Besides DRUG SUBSTANCE, BI Austria shall also manufacture DRUG PRODUCT in its pharmaceutical technology unit whereby the batch records of Corautus’ former contract manufacturer for fill & finish shall form the basis for the batch records to be compiled by BI Austria and which shall be approved by Corautus for GMP batches.

2.6

Each of the PARTIES will in good faith and in accordance with the project timelines for PERIOD ONE and PERIOD TWO as set out in Exhibit 11 initiate and complete its respective tasks for the establishment of a manufacturing process for DRUG PRODUCT provided, however, that the project timelines are subject to revision under Section 7.2 of this AGREEMENT.

2.7

The PARTIES have negotiated and executed a QUALITY AGREEMENT, a copy which is attached as Exhibit 25.

2.8

Through the end of PERIOD ONE and PERIOD TWO Corautus in its function as the sponsor for the clinical development of DRUG PRODUCT shall provide BI Austria with commercially reasonable support necessary for the establishment and validation of a manufacturing process for DRUG PRODUCT. During PERIOD THREE Corautus shall inform BI Austria without unreasonable delay of any circumstances it becomes aware of which may have an influence on the manufacture of DRUG PRODUCT. Corautus quality obligations are set forth in detail in the QUALITY AGREEMENT.

2.9

BI Austria will manufacture DRUG SUBSTANCE and DRUG PRODUCT for Corautus during PERIOD THREE as more particularly described in Section 10 hereof.

2.10

Countries Covered

2.11

Exhibits that are attached hereto are incorporated in, and are deemed to be an integral part, of this AGREEMENT. Exhibits may be amended and additional exhibits may be added from time to time after execution of this AGREEMENT if so agreed on in writing by the PARTIES.

3.

DELIVERABLES OF CORAUTUS

3.1

Documentation Transfer

3.1.1

Corautus shall supply copies of documentation and/or records and any other documentation and/or records reasonably requested by BI Austria which are necessary for establishment of the manufacturing process and for GMP manufacture of DRUG PRODUCT.

3.1.2

The documents supplied by Corautus as of the EFFECTIVE DATE to enable BI Austria to provide the SERVICES are set forth in Exhibit 12.

3.2

Material Transfer

3.2.1

Corautus shall provide BI Austria with WCB vials, samples of DRUG PRODUCT, reference standard, reagents for analytical testing not commercially available and any other material in such reasonable amounts and at such times as agreed by the Project Team (as defined on Exhibit 21 of this AGREEMENT).

3.2.2

Corautus shall also supply BI Austria with such available material as is reasonably necessary for a comparison study comparing the DRUG PRODUCT manufactured at Corautus’ current manufacturer and the DRUG PRODUCT manufactured at BI Austria.

3.2.3

The material supplied by Corautus as of the EFFECTIVE DATE, and which is to be supplied, is set forth in Exhibit 13.

3.3

Assistance and Support by Corautus

3.3.1

During PERIOD ONE and PERIOD TWO Corautus shall use good faith reasonable commercial efforts to make relevant Corautus personnel available by telephone and e-mail for technical assistance to BI Austria as reasonably requested by BI Austria in writing to facilitate BI Austria’s implementation and validation of the production process of DRUG SUBSTANCE and/or DRUG PRODUCT. BI Austria will provide advance notice to Corautus regarding its desire to have access to Corautus personnel.

3.3.2

Corautus agrees that it will on an ongoing basis update its SPECIFICATIONS or other instructions to BI Austria so that they conform and comply with all legal and regulatory requirements which both (a) apply to the clinical development or commercialization of gene therapy products and (b) affect the manufacture of the DRUG PRODUCT. Corautus will have these obligations for those portions and only those portions of the TERRITORY in which Corautus intends to conduct clinical trials with or sell the Drug Product then being manufactured.

3.3.3

Corautus shall perform in a timely manner its obligations reflected in this AGREEMENT.

4.

EQUIPMENT

4.1

Required Equipment

4.1.1

If other equipment is needed specifically for the production or Quality Control of DRUG PRODUCT, BI Austria shall obtain Corautus’ prior written approval for the purchase of such equipment and Corautus shall pay for such equipment in such amount as Corautus shall have approved in writing. BI Austria shall own such equipment, which equipment BI Austria will not use in the production or Quality Control of other products.

4.1.2

If any additional equipment is used in the production of DRUG PRODUCT, including Quality Control, under this AGREEMENT or the QUALITY AGREEMENT, other than as specified in Sections 4.1. and 4.1.1., BI Austria shall be responsible at its own expense for purchasing, obtaining, validating, calibrating and implementing such equipment and BI Austria shall own such equipment.

4.2

Ownership and Rights to Possession

4.2.1

BI Austria shall own the equipment purchased by Corautus pursuant to Sections 4.1. and 4.1.1 but will not permit the equipment to be subject to any liens or encumbrances. Upon expiry or termination of this AGREEMENT by Corautus for any reason, provided Corautus pays all sums owed in connection with such expiration or termination, and for a period of 180 days thereafter, Corautus has the right for 1.00 Euro on at least 30 days advance notice to purchase, take possession of, and remove from BI Austria’s facility any or all of the equipment that Corautus originally purchased. Upon receipt of such notice, BI Austria will assemble and appropriately pack for shipment at Corautus’ costs all of the equipment purchased by Corautus pursuant to such notice and make same available at BI Austria ‘s facility, INCOTERM 2000 EXW (“ex works”) for pickup by a carrier selected by Corautus.

**

Confidential provision omitted and filed separately with the Securities and Exchange Commission (“SEC”), based upon a request for confidential treatment filed with the SEC.

4.3

Validation and Maintenance

4.3.1

BI Austria shall be responsible for setting-up, calibrating, cleaning, qualifying, and maintaining all equipment required in the production of DRUG PRODUCT. Corautus shall pay BI Austria the costs for qualification of the DRUG PRODUCT-dedicated equipment, which cost is included in the maximum cost for such equipment set forth on Exhibit 7.

4.3.2

BI Austria is entitled to charge to Corautus a one-time surcharge ^** of the purchase price of DRUG PRODUCT-dedicated equipment described above in Sections 4.1 and 4.1.1. for purchasing, installing, calibrating, insuring and maintaining such DRUG PRODUCT-dedicated equipment during the term of the AGREEMENT. BI Austria shall be solely responsible for (a) reasonably maintaining the DRUG PRODUCT-dedicated equipment, (b) repairing the DRUG PRODUCT-dedicated equipment as a result of ordinary and intended use of such equipment for the purposes of this AGREEMENT, (c) protecting such equipment from cross contamination with other products and (d) insuring for its replacement cost against loss of such DRUG PRODUCT-dedicated equipment. In the event that despite all reasonable maintenance and ordinary and intended use of such DRUG PRODUCT-dedicated equipment an irreparable damage occurs, it will be Corautus’ responsibility to replace such DRUG PRODUCT-dedicated equipment; provided, however, that BI Austria shall be solely responsible for costs to replace or repair any DRUG PRODUCT-dedicated equipment that is damaged due to (a) any abnormal or unintended uses of such equipment, (b) any accident, fire, flood or other incident for which BI Austria’s insurance provides coverage, or (c) the failure to reasonably maintain the DRUG PRODUCT-dedicated equipment. The above one time surcharge ^** is included in the maximum costs for such equipment set forth in Exhibit 7.

5.

MATERIALS

5.1

CORAUTUS WCB

5.1.1

Corautus shall provide the CORAUTUS WCB together with a certificate of analysis and a characterization report certifying fitness of the WCB for GMP production purposes.

5.1.2

BI Austria shall conduct incoming tests for viability, identity, plasmid retention, limited bacteriophage testing and purity. BI Austria shall issue a COA certifying the test results and compliance with SPECIFICATIONS and shall use such compliant WCB for the manufacture of DRUG PRODUCT. BI Austria will notify Corautus if the WCB is not satisfactory according to the incoming tests and can not be used for the manufacture of DRUG PRODUCT. BI Austria will maintain records of usage of the WCB and will inform Corautus of needs for additional quantities or changes in characteristics thereof in a timely manner for use in any subsequent production.

**

Confidential provision omitted and filed separately with the Securities and Exchange Commission (“SEC”), based upon a request for confidential treatment filed with the SEC.

5.1.3

Ownership and Insurance

5.1.4

Handling and Storage

5.2

Resins, Raw Materials and Storage Containers

5.2.1

BI Austria shall purchase all resins, raw materials and storage containers required for the manufacture and storage of DRUG PRODUCT.

5.2.2

It is acknowledged that BI Austria has established and qualified suppliers for resins, raw materials and storage containers and the PARTIES shall mutually agree on the respective SPECIFICATIONS. Corautus may review the vendor qualification program / documentation in the course of the annual audit.

5.2.3

During PERIOD ONE and PERIOD TWO BI Austria will charge the following flat rate for services related to ordering, release testing, storage and weighing:

**

Confidential provision omitted and filed separately with the Securities and Exchange Commission (“SEC”), based upon a request for confidential treatment filed with the SEC.

6.

BI Austria SERVICES

6.1.

BI Austria Facilities

6.1.1

BI Austria shall be manufacturing DRUG PRODUCT at its facilities at Dr. Boehringer-Gasse 5 – 11, A-1121 Vienna, Austria. A description of the facilities showing the areas designated for manufacture of DRUG PRODUCT are set out in Exhibit 14 attached.

6.1.2

BI Austria’s facilities shall have, and BI Austria shall continuously maintain, all required authorizations and permits necessary for the manufacture of DRUG PRODUCT for clinical trials and commercial sale for use in humans.

6.1.3

For said facilities, BI Austria has established, or shall establish as necessary, GMP compliant rules concerning clothing, hygiene, personnel and material flow, safety, and observations of SOPs.

6.2

BI Austria Documentation and Set-Up

6.2.1

BI Austria shall study the relevant documentation provided by Corautus.

6.2.2

BI Austria shall draft all necessary documentation, including SPECIFICATIONS, MASTER BATCH RECORD and SOPs required for the manufacture of DRUG PRODUCT, taking into account the documentation supplied by Corautus. The documentation listed in Exhibit 15 shall be reviewed and approved by Corautus. Any additional documentation generated by BI Austria under this AGREEMENT shall be reviewed, approved, and supplied to Corautus , as the PARTIES may agree.

**

Confidential provision omitted and filed separately with the Securities and Exchange Commission (“SEC”), based upon a request for confidential treatment filed with the SEC.

6.3

FEASIBILITY STUDY

6.3.1

BI Austria has conducted a FEASIBILITY STUDY as set forth in Exhibit 6 in order to select an E. coli host and fermentation process mode for the manufacture of DRUG SUBSTANCE. Prior to the performance of the ^** CONFIRMATORY BATCHES the PARTIES agreed upon the host best suited for fermentation of the of DRUG SUBSTANCE (the “SELECTED WCB”) and on the fed-batch mode to be applied for fermentation.

6.3.2

As the DRUG SUBSTANCE from the ** CONFIRMATORY BATCHES is of experimental nature and does not meet GMP requirements, Corautus warrants that it shall not use such DRUG SUBSTANCE in humans.

6.4

Method Transfer Services

6.4.1

The BI Austria plasmid DNA analytical methods for testing of DRUG SUBSTANCE and DRUG PRODUCT shall be applied as far as applicable.

6.4.2

BI Austria shall perform certain experiments to evaluate the feasibility of the BI Austria methods for DRUG SUBSTANCE and DRUG PRODUCT.

6.4.3

BI Austria shall provide to Corautus appropriate METHOD TRANSFER SERVICES for two (2) methods, i.e. the RNA and the Quantitative Potency assays as agreed to by the PARTIES in separate written protocols, including documentation and implementation of both aforementioned analytical methods for in-process and DRUG PRODUCT release testing. The pricing contained in Exhibit 16 includes the cost of all two assays.

6.4.4

Costs for method transfer are defined in Exhibit 16.

6.5

Establishment of Production Process for DRUG PRODUCT

6.5.1

Corautus requests that BI Austria shall establish a fermentation and purification process for DRUG SUBSTANCE using the SELECTED WCB and BI Austria’s proprietary production technology for plasmid DNA products at a 220 L fermentation scale.

6.5.2

For the manufacture of DRUG PRODUCT BI Austria shall apply a fill and finish process which is based on the process applied at Corautus’ former contract manufacturer for fill and finish.

**

Confidential provision omitted and filed separately with the Securities and Exchange Commission (“SEC”), based upon a request for confidential treatment filed with the SEC.

6.6

Implementation Batches

6.6.1

After the FEASIBILITY STUDY and the performance of the CONFIRMATORY BATCHES, BI Austria shall produce two (2) ^** working volume IMPLEMENTATION BATCHES for DRUG SUBSTANCE, media fills and two (2) IMPLEMENTATION BATCHES for DRUG PRODUCT. Pursuant to the mutually agreed production requirements set forth in Exhibit 20 BI Austria shall establish a ^** fermentation scale and for purification a scale with a yield of ** grams DRUG SUBSTANCE per sublot.

6.6.2

The IMPLEMENTATION BATCHES shall be produced in the GMP production units at BI Austria to ensure the technical equipment is qualified with respect to the specific requirements for the later GMP manufacture of DRUG PRODUCT.

6.6.3

BI Austria shall ferment and purify each IMPLEMENTATION BATCH in accordance with the process description which shall be established in a MASTER BATCH RECORD, to be drawn up by BI Austria, reviewed by Corautus and released by BI Austria Quality Management.

6.6.4

BI Austria shall conduct in-process control testing on each manufacturing run and also conduct release testing of the IMPLEMENTATION BATCHES according to the DRUG PRODUCT SPECIFICATIONS. Corautus will conduct any release testing for methods not transferred to BI Austria.

6.6.5

BI Austria shall warehouse DRUG PRODUCT produced in the IMPLEMENTATION BATCHES as requested by Corautus. Corautus shall decide on either disposing, or, provided the DRUG PRODUCT meets SPECIFICATIONS, shipping such DRUG PRODUCT to Corautus.

6.6.6

As the DRUG PRODUCT from the IMPLEMENTATION BATCHES is of experimental nature and does not meet all GMP requirements, Corautus warrants that it shall not use such DRUG PRODUCT in humans.

6.6.7

The PARTIES shall consider the yield and purity of the IMPLEMENTATION BATCHES and if the IMPLEMENTATION BATCHES do not meet the expected purity standards or expected yields based on the DRUG PRODUCT SPECIFICATIONS the PARTIES will come to an agreement on further steps. In such events both PARTIES shall use commercially reasonable efforts to arrive at a mutually acceptable solution. For work packages in Exhibit 16 which are not marked as “estimates” prices shall be final prices. However, if the scope of certain work packages is changed upon written agreement by both PARTIES prices shall be adjusted accordingly.

**

Confidential provision omitted and filed separately with the Securities and Exchange Commission (“SEC”), based upon a request for confidential treatment filed with the SEC.

6.7

Batches for Reference Standard and Clinical Trials

6.7.1

BI Austria shall manufacture such quantities of DRUG SUBSTANCE and DRUG PRODUCT for the reference standard and human clinical trials as set forth in the SERVICES in Exhibit 7 and in accordance with the mutually agreed production requirements set forth in Exhibit 20.

6.7.2

As set forth in the project timelines in Exhibit 11, BI Austria shall manufacture, release, store and cause delivery of DRUG SUBSTANCE and DRUG PRODUCT for the reference standard and human clinical trials in accordance with the TESTING SPECIFICATIONS and the MASTER BATCH RECORDS reviewed and approved by Corautus, the QUALITY AGREEMENT and GMP and all applicable laws, regulations and ordinances as required in the TERRITORY.

6.7.3

Corautus shall conduct any release testing for methods not transferred to BI Austria as indicated in Exhibit 3 and 5.

6.8

Conformance Batches

6.8.1

BI Austria shall manufacture CONFORMANCE BATCHES which shall be at least three (3) consecutive BATCHES, in accordance with the timeline set forth in Exhibit 11 of this AGREEMENT and subject to Section 6.

6.8.2

The CONFORMANCE BATCHES shall be manufactured at the same fermentation and purification scale as the batches for the reference standard and the clinical trials (see Section 6.7).

6.8.3

The DRUG PRODUCT produced in the CONFORMANCE BATCHES is intended for clinical use and/or market supply by Corautus for use in humans.

6.8.4

BI Austria shall cause each CONFORMANCE BATCH to undergo in-process control testing, and release testing according to the DRUG PRODUCT SPECIFICATIONS using validated methods. BI Austria shall manufacture, release, store and cause delivery of the CONFORMANCE BATCHES in accordance with the TESTING SPECIFICATIONS and the MASTER BATCH RECORDS reviewed and approved by Corautus, the QUALITY AGREEMENT and GMP and all applicable laws, regulations and ordinances as required in the TERRITORY.

6.8.5

Corautus shall conduct any release testing for methods not transferred to BI Austria.

6.9

Labeling and Packaging

6.9.1

As requested by Corautus, BI Austria shall label and package clinical material in accordance with Corautus’ requirements and at Corautus’ costs and BI Austria shall charge market prices therefor as customary in the biopharmaceutical industry.

6.10

Stability Studies

7.

TIMETABLE AND INCENTIVES

7.1

The PARTIES have agreed to a timeline for the SERVICES as set out in Exhibit 11.

7.2

The PARTIES will use commercially reasonable efforts to meet the expected timelines. However, if a PARTY becomes aware of circumstances which suggest that the estimated timelines in Exhibit 11 will not be met, such PARTY shall notify the other PARTY within a reasonable period of time and the PARTIES will agree on further steps. In such events both PARTIES shall use commercially reasonable efforts to arrive at a mutually acceptable solution. Adjustments of the timeline shall not adjust the pricing of the SERVICES under Exhibit 7 unless Corautus has requested or caused a delay of the commencement of the CONFORMANCE BATCHES as permitted under Section 6 hereof, and as a result, the CONFORMANCE BATCHES are completed after **. The SERVICES attributable to the CONFORMANCE BATCHES which are performed after ^** may have the price adjusted therefor in accordance with Section 17.2.1, subsection (i) and (ii) to reflect price increases from and after ^** .

7.3

Each PARTY acknowledges and agrees that it shall perform in a timely manner all of its obligations in this AGREEMENT.

7.4

As an incentive to BI Austria, in the event BI Austria timely and fully completes all of its obligations and delivers the DRUG SUBSTANCE and DRUG PRODUCT required under Section 6.7.1 and 6.7.2 on or before **, then Corautus shall pay a bonus to BI Austria of United States dollars ** within thirty (30) days of such date. If BI Austria fails to timely and fully complete all of its obligations and does not deliver DRUG SUBSTANCE and DRUG PRODUCT required under Section 6.7.1 and 6.7.2 on or before March 17,2006, then BI Austria shall credit United States dollars ** to Corautus.

8.

DELAYED APPROVAL OF CLINICAL TRIALS

8.1.

Corautus shall promptly notify BI Austria in the event that one (1) and/or several approval processes of regulatory authorities for the DRUG PRODUCT is/are unexpectedly delayed and such delays may have an impact on the SERVICES performed by BI Austria and the manufacturing timelines.

**

Confidential provision omitted and filed separately with the Securities and Exchange Commission (“SEC”), based upon a request for confidential treatment filed with the SEC.

8.2.

In such event, the co-operation between the PARTIES on DRUG PRODUCT is continued, and if the Rolling Forecast Model is already in effect, Corautus’ obligations for any PURCHASE ORDER for the red zone of the Rolling Forecast (Section 10.4) remain unchanged; whereas for the blue zone of the Rolling Forecast Model Corautus can alter its forecast by ** percent but ** in each one of the four (4) respective quarters.

9.

STERILITY DRUG SUBSTANCE

10.

CLINICAL AND COMMERCIAL MANUFACTURE DURING PERIOD THREE

10.1.

Product Supply

10.1.1

BI Austria covenants that all DRUG PRODUCT manufactured by BI Austria during PERIOD THREE and supplied to Corautus, or to Corautus’ representatives or AGENTS, for clinical use or for market supply, shall be manufactured, released, stored and delivered to the carrier designated by Corautus in accordance with the SPECIFICATIONS (in particular, the DRUG PRODUCT SPECIFICATIONS and the MASTER BATCH RECORDS), QUALITY AGREEMENT and GMP and all applicable laws, regulations and ordinances as required in the TERRITORY.

10.1.2

BI Austria warrants that all DRUG PRODUCT manufactured by BI Austria during PERIOD THREE for clinical use or market supply meets the DRUG PRODUCT SPECIFICATIONS.

10.1.3

Details of the MANUFACTURER RELEASE, Quality Assurance (also called Quality Management), Quality Control, Validation, Inspections, Audits and other Regulatory requirements are detailed in the QUALITY AGREEMENT, and Corautus and BI Austria each agree to comply with its obligations under the QUALITY AGREEMENT.

10.2.

Preliminary Market Launch Date and Product Estimate

10.2.1

Corautus expects to file the BLA for DRUG PRODUCT in the United States ^** . First launch of DRUG PRODUCT in the United States market is expected ^** . These dates are projections only, are non-binding and are subject to change.

**

Confidential provision omitted and filed separately with the Securities and Exchange Commission (“SEC”), based upon a request for confidential treatment filed with the SEC.

10.2.2

Corautus preliminary, non-binding forecast for the first three (3) years after market launch is given in Exhibit 17.

10.2.3

For early market supply (meaning the first two years after DRUG SUBSTANCE from the CONFORMANCE BATCHES has been used up) DRUG SUBSTANCE shall be manufactured at the same scale as the CONFORMANCE BATCHES (see section 6.8.2); nothing in this sentence shall limit either PARTY’s obligations set forth in Sections 10.3. and 10.4.

10.3.

Minimum and Maximum Volume

10.3.1

Corautus shall inform BI Austria on the minimum and maximum volume of the amount of DRUG PRODUCT, in conformity with Corautus’ market projections, for which BI Austria is obliged to reserve manufacturing capacity.

10.3.2

Corautus may from time to time by written notice to BI Austria modify its minimum and maximum volumes, such revised minimums and maximums to take effect on the date specified in such notice, but no sooner than two (2) years from the date of such notice. However, the minimum volume to be purchased shall never be less than such amount of DRUG PRODUCT per applicable calendar year as set forth in Section 10.3.4 which incorporates at least ** of DRUG SUBSTANCE. As soon as the dose of DRUG SUBSTANCE per vial of DRUG PRODUCT is established for commercial supply, the PARTIES agree that the minimum and maximum volumes as set forth in this Section 10.3 shall be restated in vials of DRUG PRODUCT instead of grams of DRUG SUBSTANCE. However, such determination shall, with regard to the quantities of DRUG SUBSTANCE, neither alter Corautus’ purchase obligations under this Section 10.3. nor BI Austria’s obligation to reserve manufacturing capacity pursuant to Section 10.3.1.

10.3.3

The PARTIES agree that the ratio of the minimum volume to the maximum volume shall be ** . The maximum volume however, shall not exceed ** DRUG SUBSTANCE unless agreed to by BI Austria in writing. Once sufficient demand for DRUG SUBSTANCE is established in PERIOD THREE and depending on Corautus’ DRUG SUBSTANCE requirements, the PARTIES shall negotiate in good faith the procedure and costs for an upscale of the manufacturing process for DRUG SUBSTANCE and DRUG PRODUCT.

10.3.4

Commencing in the calendar year for which the red zone of the Rolling Forecast Model under Section 10.4 is first effective and binding, Corautus shall be obligated to purchase in any year during the Term of this AGREEMENT at least the then current minimum volume for such year established under this Section 10.3.

**

Confidential provision omitted and filed separately with the Securities and Exchange Commission (“SEC”), based upon a request for confidential treatment filed with the SEC.

10.4.

Rolling Forecast

10.4.1

In order to try to plan future DRUG PRODUCT requirements for clinical and/or commercial supply during PERIOD THREE, Corautus shall provide three-year rolling forecasts with fixed and variable quantities and timelines. The first three-year Rolling Forecast shall be provided by Corautus no later than two years before the first delivery date requested by Corautus of DRUG PRODUCT in PERIOD THREE..

10.4.2

The details and timeline for the commercial manufacture of DRUG PRODUCT shall be done in accordance with the Rolling Forecast Model, which is attached to this AGREEMENT as Exhibit 18.

10.4.3

After the first forecast has been submitted by Corautus to BI Austria, successive forecasts shall be submitted on a quarterly basis at the latest on every first day of every new calendar quarter.

10.5.

Packaging/Labeling by BI Austria

10.6.

Warehousing at BI Austria Facilities

10.6.1

BI Austria shall warehouse DRUG PRODUCT produced under GMP during PERIOD THREE. BI Austria shall warehouse DRUG PRODUCT free of charge up to the DATE AVAILABLE FOR DELIVERY plus a further ** months.

10.6.2

DRUG PRODUCT not subject to FINAL RELEASE by Corautus shall be properly quarantined by BI Austria from DRUG PRODUCT which has undergone FINAL RELEASE.

10.6.3

During PERIOD THREE, Corautus shall specify the DATE(S) AVAILABLE FOR DELIVERY on the PURCHASE ORDER for DRUG PRODUCT. BI Austria shall review and approve any such PURCHASE ORDER within four (4) weeks of receipt. BI Austria is obligated to accept all PURCHASE ORDERS that are consistent with the terms of this AGREEMENT. BI Austria shall deliver on a timely basis the released DRUG PRODUCT in accordance with the PURCHASE ORDER and this AGREEMENT.

**

Confidential provision omitted and filed separately with the Securities and Exchange Commission (“SEC”), based upon a request for confidential treatment filed with the SEC.

10.6.4

Corautus shall be obligated to buy and BI Austria shall be obligated to manufacture only the quantities of DRUG PRODUCT which are subject of a PURCHASE ORDER.

10.6.5

On or before the DATE AVAILABLE FOR DELIVERY, BI Austria shall approve the BATCH RECORDS, investigate all deviations, perform the MANUFACTURER RELEASE and supply Corautus with documentation pursuant to Sections 11.3 for Corautus documentation review and batch FINAL RELEASE.

10.7.

Release

10.7.1

BI Austria shall be responsible for the MANUFACTURER RELEASE which shall be completed no later than ninety (90) calendar days from the Manufacturing Date of a batch.

10.7.2

Corautus is responsible for the FINAL RELEASE of DRUG PRODUCT which shall be performed no later than sixty (60) calendar days from the MANUFACTURER RELEASE.

10.7.3

BI Austria and Corautus shall establish an acceptable GMP procedure for BATCH RECORD review in accordance with Section 12.2. Original BATCH RECORDS will be completed and available for review on site at BI Austria by Corautus upon request after MANUFACTURER RELEASE of each clinical and/or commercial BATCH. The review and approval of BATCH RECORDS is detailed in the QUALITY AGREEMENT.

10.7.4

BI Austria will undertake all warehousing and distribution activities in accordance with GMP and the applicable SPECIFICATIONS, as detailed in the QUALITY AGREEMENT.

11.

SHIPMENT OF DRUG PRODUCT

11.1

All DRUG PRODUCT (and any samples thereof) shall be shipped to Corautus according to the Incoterm 2000 EXW (“ex works”) BI Austria’s facility.

11.2

Corautus shall be responsible for obtaining any import license or other official authorization and carrying out any other customs formalities necessary for importation of the DRUG PRODUCT, and for paying for all customs formalities as well as duties, taxes, and other official charges payable upon importation.

11.3

Drug Product Delivery and Delivery Documents

11.3.1

For DRUG PRODUCT manufactured and shipped during PERIOD TWO AND PERIOD THREE, BI Austria shall submit an invoice together with a packing list and a certificate of analysis (“COA”). For DRUG PRODUCT manufactured under GMP BI Austria shall also issue and submit a certificate of compliance (“COC”).

11.3.2

The invoice shall state the quantity of DRUG PRODUCT in such shipment and the price therefore in accordance with Section 17.1.1 of this AGREEMENT. All invoices and other

11.3.3

In the event that DRUG PRODUCT which has been ordered by Corautus pursuant to a PURCHASE ORDER is not shipped to Corautus within ninety (90) calendar days of FINAL RELEASE for reasons attributable to Corautus (e.g. lack of shipping instructions, etc.) the risk of the deterioration or perishing of the DRUG PRODUCT for whatever reason passes to Corautus unless such deterioration or perishing was caused by a willful or grossly negligent act or omission by BI Austria. However, BI Austria shall continue to warehouse DRUG PRODUCT in accordance with Section 10.6. BI Austria shall render invoice and Corautus shall pay for such DRUG PRODUCT when the invoice becomes due. BI Austria is entitled to claim reimbursement for storage costs incurred after expiry of the ninety (90) calendar day time limit.

11.4

Ownership and Insurance Liabilities

11.4.1

BI Austria shall retain title to the work-in progress and to any batch which has not yet been paid for in full by Corautus. However, this does not affect Corautus rights set forth in Section 5.1.3, 20.1.2 and 20.2.1 of this AGREEMENT. Title to a batch shall pass to Corautus on payment in full to BI Austria for the batch.

11.4.2

Corautus shall obtain the appropriate insurance on the batch when the batch is shipped from BI Austria facilities.

11.4.3

BI Austria shall hold appropriate insurance for the work-in-progress and batches which are on site at BI Austria facilities.

12.

DOCUMENTATION

12.1

BI Austria will retain complete, accurate and authentic documents and records created by BI Austria for each batch, as required by GMP.

12.2

During the initial manufacture of GMP batches there will be a qualification period in which Corautus will undertake to qualify BI Austria as a manufacturer of DRUG PRODUCT (“Qualification Period”). The PARTIES agree that during the Qualification Period BI Austria shall copy and send the full batch documentation for ^** batches (i.e. the ** for Ph II, the ** for Ph III and the ** CONFORMANCE BATCHES) to Corautus.

12.3

The documents to be sent to Corautus during the Qualification Period and after the Qualification Period are set forth in the QUALITY AGREEMENT.

**

Confidential provision omitted and filed separately with the Securities and Exchange Commission (“SEC”), based upon a request for confidential treatment filed with the SEC.

12.4

Documents and records created by and for BI Austria shall be in German or English. The specific documents to be drafted in English or for which BI Austria will provide English language translations all at the expense of BI Austria except as provided in Section 12.4.1 are listed in Exhibit 19.

12.4.1

The translation cost of that portion of Exhibit 19 which consists of Procedures of Analytical Methods (bullet 4 on Exhibit 19) shall be borne equally by the PARTIES, with the total estimated cost of such translations not to exceed Euro 10.000.

12.4.2

Documents other than those listed in Exhibit 19 shall only be provided if agreed to by BI Austria. Translation costs shall be borne by Corautus.

12.5

In addition to the documents BI Austria shall provide under Section 12.3, BI Austria shall provide a trend analysis of the process which will include in-process data and results of tests reported in the COA for the GMP batches. All data on the CONFORMANCE BATCHES will be provided in the respective validation documentation. During PERIOD THREE the trend analysis shall be provided in the Annual Product Review, as such term is defined in the Quality AGREEMENT.

12.6

All documentation shall be available on-site at the BI Austria facilities for Corautus’ review.

13.

QUALITY CONTROL AND QUALITY MANAGEMENT

13.1

Validation Services

13.1.1

Validation Master Plan

13.1.2

Facility, Equipment and Utility Qualification

13.1.3

Process

13.1.4

Test Methods

13.2

Quality Control

13.2.1

BI Austria shall maintain a separate Quality Control unit which shall operate separately from the production staff for ensuring Quality Control in the manufacture of DRUG PRODUCT.

13.2.2

The Quality Control unit at BI Austria will conduct the testing of raw materials, resins and consumables, packaging components, in-process products, and DRUG PRODUCT.

13.3

Quality Management

13.3.1

BI Austria shall maintain a Quality Management unit, which will be separate from the Quality Control unit and production staff. The responsibilities of the Quality Management unit are detailed in the QUALITY AGREEMENT.

13.3.2

BI Austria’s Quality Management unit shall review and approve all BATCH RECORDS and shall investigate all deviations on such BATCH RECORDS on a timely basis, but in any event within ninety (90) calendar days from the Manufacturing Date of a BATCH. BI Austria shall follow-up with corrective and preventive actions, as required.

13.3.3

BI Austria’s Quality Management unit shall also ensure that BI Austria’s facilities and manufacturing operations for DRUG PRODUCT are in compliance with the SPECIFICATIONS, GMP, BI Austria’s SOPs and with any other applicable law or regulation governing a contract manufacturer of biopharmaceuticals domiciled in Austria and in effect during the time of manufacture of DRUG PRODUCT.

13.3.4

The Quality Management unit at BI Austria shall maintain appropriate SOPs, review and approve VALIDATION protocols, review proposed process changes and determine whether re-validation is required, approve all procedures or applicable SPECIFICATIONS, particularly those effecting identity, quality and purity of DRUG PRODUCT.

13.3.5

The BI Austria Quality Management unit shall ensure that changes in packaging, equipment, processes, warehousing and distribution that could affect DRUG PRODUCT effectiveness or DRUG PRODUCT characteristics are re-validated.

13.4

Change Control

14.

REGULATORY

14.1

Regulatory Compliance

14.1.1

BI Austria and Corautus shall exercise all reasonable skill, care and diligence customary in the industry in the performance of their duties under this AGREEMENT and in accordance with all applicable GMP-requirements.

14.1.2

BI Austria shall obtain and maintain all permits required under Austrian legislation in order to manufacture DRUG PRODUCT. BI Austria shall file and maintain for its facility in Austria a Site Master File and a Drug Master File which will be provided or made available to the HEALTH AUTHORITIES whenever requested.

14.1.3

BI Austria shall notify Corautus within seven (7) days of receipt of any communication with any HEALTH AUTHORITY concerning the manufacture of DRUG PRODUCT and shall co-operate with Corautus in the scheduling of any planned inspection concerning the manufacture of DRUG PRODUCT.

14.1.4

In the event BI Austria receives a Form 483 notice from the FDA or any equivalent European notice with respect to its facilities, its manufacturing processes, its Quality Control and Quality Management or the SOPs concerning or impacting DRUG PRODUCT, it shall advise Corautus within thirty (30) calendar days of receipt of such notice.

14.2

Manufacturing Audits and Regulatory Inspections

14.2.1

Corautus rights and obligations with regard to audits and regulatory inspections are set forth in the QUALITY AGREEMENT.

14.2.2

BI Austria shall take immediate steps to address and correct any/all concerns raised by a HEALTH AUTHORITY, including, without limitation, fully cooperating with Corautus in securing FDA acceptance of BI Austria as the manufacturer of the DRUG PRODUCT and will correct any deficiencies or perform any modifications that prevent it from being so accepted as follows:

14.3

Regulatory Filings

14.3.1

The PARTIES will mutually agree as to each PARTY’s responsibilities in ensuring the requisite information required for the regulatory filings is available and submitted. The PARTIES shall work together to ensure all necessary and sufficient information and data for the Chemistry Manufacturing and Control (“CMC”) section of any regulatory filing is completed as required and which shall include BI Austria’s participation in the writing of, and approval of, the sections of the CMC sections directed to the DRUG PRODUCT as produced by BI Austria. Any CMC section shall be written in English. BI Austria shall cooperate with Corautus at Corautus’ expense to fulfill its obligations necessary for such regulatory filings.

14.3.2

Corautus shall submit any regulatory correspondence, submissions or updates thereof by Corautus with any regulatory authority concerning DRUG PRODUCT or manufacture of DRUG PRODUCT at the BI Austria facilities for review and approval in writing by BI Austria prior to making them available to such regulatory authority. The timelines for BI Austria’s review and approval of such documents shall not exceed thirty (30) days unless otherwise agreed between the PARTIES.

15.

CORAUTUS’ ACCESS TO BI AUSTRIA FACILITIES

15.1

Corautus shall have the right to have technical personnel, namely two (2) employees, present in the production facilities during GMP manufacturing campaigns of DRUG PRODUCT.

15.2

Corautus personnel may be in attendance during clinical and/or commercial manufacture of DRUG PRODUCT during a scheduled audit or at request by BI Austria.

15.3

BI Austria shall accommodate Corautus personnel during such visits by providing an office area with access to photocopiers, telephone (voice and data) and facsimile.

16.

DISPUTE RESOLUTION FOR NON-CONFORMING DRUG PRODUCT

16.1

Rejection Procedure / Confirmatory Third PARTY Testing

16.1.1

Within forty-five (45) calendar days of receipt of any DRUG PRODUCT during PERIOD TWO or PERIOD THREE at such destination as may be designated by Corautus, Corautus may perform such sampling and tests to determine whether the DRUG PRODUCT meets the applicable DRUG PRODUCT SPECIFICATIONS, GMP and the other requirements of this AGREEMENT. If Corautus rejects any DRUG PRODUCT in accordance with this Section 16.1.1, Corautus shall within such forty-five (45) working days of receipt of such DRUG PRODUCT inform BI Austria of its rejection of the batches of DRUG PRODUCT and the reasons therefor.

16.1.2

If Corautus does not so notify BI Austria, Corautus shall be deemed to have accepted the batches.

16.1.3

If the PARTIES disagree as to whether or not the said quantity of DRUG PRODUCT is non-conforming, then BI Austria shall re-test the respective retain samples, and other samples as agreed between the PARTIES.

16.1.4

If the PARTIES continue to disagree as to whether or not the said quantity of DRUG PRODUCT meets DRUG PRODUCT SPECIFICATIONS, or is GMP grade, and suitable for FINAL RELEASE, then such disagreement shall be submitted to the Steering Committee (see Section 18.8) for dispute resolution.

16.1.5

If the Steering Committee can not resolve such disagreement, a qualified independent party, acceptable to both PARTIES, will determine from a scientific perspective if the DRUG PRODUCT meets DRUG PRODUCT SPECIFICATIONS, is GMP grade and suitable for FINAL RELEASE. The resulting scientific determination will be final and binding on BI Austria and Corautus. BI Austria will bear all cost of the third party evaluation if the testing demonstrates that the DRUG PRODUCT is non-conforming. If the DRUG PRODUCT is determined to be conforming, then Corautus shall bear all costs of the third party evaluation.

16.2

Replacement

16.2.1

If, during PERIOD TWO or PERIOD THREE, any DRUG PRODUCT is confirmed to be non-conforming in accordance with Section 16.1.5, BI Austria will promptly or, if the DRUG PRODUCT needs to be remanufactured, no longer than within six (6) months after Corautus’ or any consignee’s receipt of such non-conforming DRUG PRODUCT, at Corautus’ option either replace such non-conforming DRUG PRODUCT or credit Corautus for such DRUG PRODUCT if already paid for by Corautus, provided, that BI Austria is notified promptly in writing (including a reasonable description of the alleged non-conformance) upon discovery of any non-conformance of the DRUG PRODUCT. Other than replacement of non-conforming DRUG PRODUCT and associated shipping and restocking charges and as otherwise provided in Section 23.2, subsection (b) and (c), BI Austria shall not be liable for any further claims by Corautus resulting from such delivery of non-conforming DRUG PRODUCT. Section 23.5 applies to any liability of BI Austria under this Section 16.2.

16.2.2

If in the good faith judgment of Corautus, it is necessary or appropriate to withdraw or recall DRUG PRODUCT or issue an advisory letter regarding the DRUG PRODUCT, then Corautus may undertake such withdrawal, recall or issue such advisory letter after consultation with BI Austria. Any withdrawal or recall of DRUG PRODUCT shall be in the sole discretion of Corautus. BI Austria will cooperate fully with Corautus in the event of any recall or withdrawal and will provide at Corautus’ expense, such assistance in connection therewith as Corautus may reasonably request.

16.2.3

Any confirmed non-conforming PRODUCT shall at the option of BI Austria either be returned to BI Austria’s facilities or destroyed in either