Document:

EX-10.10

 

Exhibit 10.10

	 	 	 
	 
	 	*** TEXT OMITTED AND FILED SEPARATELY

CONFIDENTIAL TREATMENT REQUESTED

SUPPLY AGREEMENT

THIS AGREEMENT is made this 4th day of April, 2005 by and between

Diosynth B.V., a corporation duly organized and existing under the laws of the Netherlands
and having its offices at Kloosterstraat 6, 5349 AB Oss, the Netherlands (hereinafter referred to
as (“Diosynth”),

and

BIODEL Inc. (Biodel), a corporation duly organized and existing under the laws of the State
of Delaware in the United States of America and having its offices at 6 Christopher Columbus
Avenue, Danbury CT 06810 (hereinafter referred to as `BIODEL”),

WITNESSETH:

WHEREAS Diosynth is engaged in the development, manufacture and supply of active substances for
pharmaceutical products;

WHEREAS Diosynth possesses the right to manufacture, use and sell a certain recombinant insulin
product in certain countries;

WHEREAS BIODEL is engaged in the development of its proprietary formulation(s) of insulin and upon
successful development wishes to commercialize or have commercialized such formulation,

WHEREAS BIODEL wishes to purchase from Diosynth recombinant human insulin to be used in its
formulation(s) and Diosynth is willing to supply the recombinant human insulin to BIODEL according
to the terms and conditions as set forth is this Agreement;

NOW, THEREFORE, THE PARTIES HERETO AGREE AS FOLLOWS:

Article 1.Supply and Specifications.

	1.1	 	Diosynth herewith agrees to supply BIODEL and BIODEL herewith agrees
to purchase from Diosynth recombinant human insulin (hereinafter referred
to as “Substance”) as further described and specified in Appendix A hereto
attached.

 

2

	1.2	 	During the development of the insulin formulation by BIODEL, Diosynth will supply BIODEL with
the Substance in such quantities as BIODEL shall order and estimated not to exceed the
following:
	 
	 	 	[...***...]

[...***...]
	 
	1.3	 	In case the insulin formulation(s) are developed successfully and in the event BIODEL wishes
to sell its insulin formulation on a commercial basis, Diosynth will supply BIODEL with the
Substance in such quantities as BIODEL shall order. It is foreseen that BIODEL will indicate
the following quantities as its estimated commercial needs for the product:
	 
	 	 	[...***...]

[...***...]

[...***...]

[...***...]
	 
	1.4	 	During the term of this Agreement, Diosynth agrees to keep and maintain a Drug Master File
for the Substance in the United States of America, and to authorize BIODEL to incorporate by
reference all information and documentation contained therein.

Article 2. Forecast and Orders

Within fifteen (15) days from the beginning of each calendar quarter BIODEL shall furnish to
Diosynth a rolling forecast of its requirements of the Substance during the next four calendar
quarters whereby the required quantities for the first calendar quarter shall be a binding order
for supply of the Substance and shall not deviate more than 20% (twenty percent) from the forecast
formerly provided to Diosynth.

Article 3. Delivery

	3.1	 	Diosynth will deliver all orders for supply which are within the forecast given according to
Article 2 herein within the date stipulated in the order. Diosynth will use its best
commercial efforts to deliver as soon as possible any quantities in excess of the purchase
order as determined in Article 1.3.

	3.2	 	Diosynth will deliver the Product to BIODEL within the date stipulated in the firm purchase
order.

 

3

	3.3	 	Delivery of each batch of each Substance shall be effectuated DDP BIODEL’s or its designee’s
manufacturing facility (INCOTERMS 2000). Each batch of the Substance shall be accompanied by a
certificate of analysis and an invoice.
	 
	3.4	 	Upon dispatch samples of each batch shall be taken at random and sealed by Diosynth and
thereupon shall be stored for reference by Diosynth for a period of 24 (twenty-four) months.

Article 4. Non-conformity

	4.1	 	All batches of Substance delivered by Diosynth to BIODEL shall comply with the specifications
as set forth in Appendix A and shall be manufactured according to applicable regulations of
Good Manufacturing Practices.
	 
	4.2	 	Within thirty (30) days of delivery of the batches of Substance, BIODEL shall inform Diosynth
of any non-conformance of the delivered batch(es) with the specifications set out in Appendix
A. In the event it appears that such non-conformance is due to faulty manufacture of the
relevant batch(es) of Substance, which fact shall be established on basis of the corresponding
sealed samples retained by Diosynth, Diosynth shall replace such batches free of charge. In
the event BIODEL does not notify Diosynth of any non-conformance within said period, the
relevant batches shall be deemed to be in conformance with the specifications and BIODEL shall
then have no right to reject the same.
	 
	4.3	 	If the parties fail to agree on whether a batch is defective or on the responsibility
therefor, the matter shall be finally determined by an expert to be nominated by agreement
between the parties, or failing agreement, by an expert, to be nominated by the President of
the International Chamber of Commerce. The said expert shall act as an expert and not as an
arbitrator, but his opinion shall be binding upon the parties and his fees and expenses shall
be borne by the party against which his decision is rendered.

Article 5. Price and Payment

	5.1	 	The purchase price of the Substance for the year 2005 shall be [...***...], whereas for supply of
the quantities in 2006 the purchase price will be [...***...].
	 
	5.2	 	Diosynth is willing to accept [...***...] as the commercial market price in the year 2004. In
this respect “commercial market price” is considered to be the price for annual quantities
greater than [...***...]. This commercial market price in the year 2004 will be used as a basis
for the determination of the commercial market price in subsequent years. To that end, on or
before September 30 of each calendar year, parties will in good faith determine the commercial
market price for the product for the following calendar year. In any case this price will not
increase, on a year by year basis, with more than the increase of the labor cost index in the
Netherlands, as published by the C.B.S. (“Central Bureau voor de Statistiek”). Diosynth will
not offer the Substance to other customers at a lower price, provided the quality and the
quantity of the Substance to that other customer is

 

4

	 	 	  substantially comparable with the quantity and quality of the Substance supplied to Biodel.

	5.3	 	Payment shall be made by BIODEL within thirty (30) days of the date of Diosynth’s invoice.

Article 6.Warranties and Representations

6.1 Diosynth warrants and represents to BIODEL that

	 	(a)	 	All Substance manufactured by Diosynth for BIODEL shall be manufactured in compliance with
the specifications as set forth in Annex A hereto;
	 
	 	(b)	 	All Substance manufactured by Diosynth for BIODEL shall be manufactured in compliance with
all applicable laws and regulations including, but not limited to, the applicable Good
Manufacturing Practices for bulk pharmaceutical ingredients;
	 
	 	(c)	 	All Substance supplied by Diosynth to BIODEL shall be manufactured at Diosynth’s plants in
Oss, the Netherlands and Gisors, France.
	 
	 	(d)	 	All Substance manufactured by Diosynth for supply to BIODEL shall be manufactured in
compliance with Diosynth’s Drug Master File filed with the United States Food and Drug
Administration`.

	6.2	 	EXCEPT AS EXPRESSLY PROVIDED HEREIN, DIOSYNTH MAKES NO OTHER WARRANTIES, EXPRESS OR IMPLIED, AS
TO THE QUALITY OR FITNESS FOR PURPOSE OF THE SUBSTANCE SUPPLIED HEREUNDER.

Article 7. Inspection

BIODEL shall have the right to inspect Diosynth’s manufacturing facilities during mutually agreed
upon times to ensure that Diosynth’s manufacture of the Substance is in compliance with applicable
regulation. The right to inspect granted to BIODEL shall not be deemed as granting to BIODEL access
to any trade secrets owned by Diosynth.

Article 8. Liability — Indemnification

	8.1	 	As manufacturer of the finished products, BIODEL shall be liable for and BIODEL shall
indemnify and hold Diosynth harmless from and against all damages, claims, causes of action,
settlement costs, including reasonable attorneys’ fees, losses or liabilities of any kind
asserted by third persons which arise from the manufacture sale and/or use of finished
products, unless such damages, claims, causes of action, settlement costs, losses or
liabilities arise out of or are attributable to any defect in the Substance due to faulty
manufacture by Diosynth.
	 
	8.2	 	Diosynth shall indemnify and hold BIODEL harmless from and against all damages, claims,
causes of action, settlement costs, including reasonable attorneys’ fees, losses or
liabilities of any kind asserted by third persons which arise out of or are attributable to
any defect in the Substance due to faulty manufacture by Diosynth.

 

5

	8.3	 	Neither party shall be liable to the other under this Agreement for any indirect or
consequential loss or damage suffered or incurred by the other party.

Article 9. Term and Termination

	9.1	 	This Agreement shall be effective as of the date first written above and shall continue to be
in force until terminated as provided herein.

	9.2	 	Notwithstanding the preceding paragraph, this Agreement may be terminated forthwith by
registered or certified mail:

	 	(a)	 	by both parties for any reason or no reason with a two year written notice; or
	 
	 	(b)	 	by either party in the event of any material breach by the other party of any of the terms
of this Agreement, unless the other party corrects such breach within said sixty (60) days period;
	 
	 	(c)	 	forthwith by either party, in the event of the other party’s liquidation, bankruptcy or
state of insolvency
	 
	 	(d)	 	by BIODEL, with 30 days written notice if a controlling regulatory authority either fails
to approve or withdraws approval of the insulin formulation(s). In that event, BIODEL will
responsible for full payment for all API delivered to BIODEL and for all API quantities on order.
In the event that the product is withdrawn by regulatory decree in a portion, but not all of the
market, then BIODEL shall have the right to reduce the minimum quantities with 30 days written
notice.

	9.3	 	[...***...]

Article 10. Mutual Confidentiality

	10.1	 	It is recognized by both BIODEL and Diosynth that during the term of this Agreement, both
BIODEL and Diosynth may disclose certain information which is confidential and proprietary.
Both parties agrees that they shall keep such Confidential Information confidential and shall
not disclose such Confidential information to any third party and shall not use such
Confidential Information for other purposes than as required to perform its obligations under
this Agreement. For purposes of this Agreement, Confidential Information shall include all
information disclosed hereunder in writing and clearly marked as “Confidential”, except any
portion thereof which:

	 	(a)	 	is known to either party before receipt thereof under this Agreement;

	 
	 	(b)	 	is disclosed in good faith to either party after acceptance
of this Agreement by a third party lawfully in possession of such
information
and not under an obligation of non-disclosure;
	 
	 	(c)	 	is or becomes part of the public domain through no fault of either party; or

	 
	 	(d)	 	is required by law to be disclosed.

	10.2	 	The obligations of both parties relating to Confidential Information shall expire upon ten
(10) years after expiration of termination of this Agreement.

 

6

Article 11. Force Majeure

	11.1	 	Any delay or failure in their performance of any of the duties or obligations of either party
hereto (except the payment of money) shall not be considered a breach of this Agreement and
the time required for performance shall be extended for a period equal to the period of such
delay, provided that such delay has been caused by or is the result of any acts of god, acts
of the public enemy, insurrections, riots, embargoes, labor disputes, including strikes,
lockouts, job actions or boycotts, fires, explosions, floods, shortages of material or energy
or other unforeseeable causes beyond the control and without the fault or negligence of the
party so affected.
	 
	11.2	 	The party so affected shall give prompt notice to the other party of such cause and shall take
whatever reasonable steps are necessary to relieve the effect of such cause as rapidly as possible.

Article 12. Hardship

Should it appear that at any time during the lifetime of this Agreement and for any reason, the
terms of this Agreement are not workable from an economical point of view, the parties to this
Agreement at the request of the party concerned shall meet within two (2) months from the date of
that request and expend their best efforts to re-establish the terms of this Agreement in a
mutually satisfactory way.

Article 13. Assignment

The parties shall not assign this Agreement or any part thereof without the prior written consent
of the other party; provided, however, (1) a party may assign this Agreement without consent of the
other to any company which through a majority of shares or otherwise directly or indirectly
controls or is controlled by or is under common control with such party; or (2) a party may assign
or sell the same without such consent in connection with the transfer or sale of substantially its
entire business to which this Agreement pertains or in the event of its merger or consolidation
with another company. Any permitted assignee shall assume all obligations of its assignor under
this Agreement. No assignment shall relieve any party of responsibility for the performance of any
accrued obligation which such party then has hereunder.

Article 14. Applicable Law and Dispute Resolution

	14.1	 	The validity, construction and performance of this Agreement shall be governed by and
construed in accordance with the internal laws of the state of New York in the United States
of America.
	 
	14.2	 	The parties shall attempt in good faith to resolve promptly any dispute arising out of or
relating to this Agreement by negotiation. If the matter can not be resolved in the normal
course of business any interested party shall give the other party written notice of any such
dispute not resolved, after which the dispute shall be referred to more senior executives of
both parties, who shall likewise attempt to resolve the dispute.

 

7

	14.3	 	If the dispute has not been resolved by negotiation within forty-five (45) days of the
disputing party’s written notice, or if the parties fail to meet within twenty (20) days as
from such notice, the parties shall endeavor to settle the dispute by mediation under the
supervision of and in accordance with the CPR Model Mediation Procedure for Business Dispute
in Europe. Unless otherwise agreed, both parties or each individual party may request the CPR
to appoint an independent mediator. The language of mediation shall be English and the seat of
mediation shall be agreed upon by both parties and, in the event parties do not timely agree,
the seat will be determined by the mediator.

	14.4	 	If the dispute has not been resolved by non-binding means as provided in 14.3 hereof within
ninety (90) days of the initiation of such procedure, the dispute shall be finally and
exclusively settled by arbitration in The Hague, or any other mutually agreed upon venue under
the Uncitral Arbitration Rules by three (3) independent arbitrators appointed in accordance
with said Rules. The appointing authority shall be The London Court of International
Arbitration in London, England. The language of the arbitration shall be English. The
arbitration shall be in lieu of any other remedy and the award shall be final, binding and
enforceable by any court having jurisdiction for that purpose.

	14.5	 	This Article shall, however, not be construed to limit or to preclude either party from
bringing any action in any court of competent jurisdiction for injunctive or other provisional
relief as necessary or appropriate.

Article 15. Miscellaneous Provisions

	15.1	 	All stipulations contained in this Agreement shall be so construed as not to infringe the
provisions of any applicable law or regulation. To the extent, and only to the extent that any
stipulation does infringe any such provisions, the same shall be deemed to be void and shall
be replaced by a stipulation conforming to the said provision and reflecting the original
purpose of the infringing stipulation as much as possible.
	 
	15.2	 	No modification of this Agreement shall be binding unless it is in writing and signed by the
parties hereto.

	 
	15.3	 	The failure by any party at any time to enforce any of the terms, provisions or conditions of
this Agreement or to exercise any right hereunder shall not constitute a waiver of the same or
affect that party’s right thereafter to enforce or exercise the
same right.
	 
	15.4	 	All notices and other communications hereunder shall be in writing and will be deemed to have
been duly given if delivered or mailed (registered mail where specifically required according to
this Agreement) as follows:

	 	 	 	 	 
	 

	 	As to Diosynth:
	 	Diosynth B.V.
	 

	 	 	 	Kloosterstraat 6
	 

	 	 	 	P.O. Box 20
	 

	 	 	 	5340 BH Oss
	 

	 	 	 	The Netherlands
	 

	 	 	 	Attention: Adriaan Sanders, API Operations Manager
	 

	 	 	 	Telephone: 31 412 662058
	 

	 	 	 	Facsimile: 31 412 652311

 

8

	 	 	 	 	 
	 

	 	As to BIODEL:
	 	Biodel Inc.
	 

	 	 	 	6 Christopher Columbus Ave.
	 

	 	 	 	Danbury CT 06810
	 

	 	 	 	Attention: Solomon Steiner, Chairman and CEO
	 

	 	 	 	Telephone: 203-798-3600
	 

	 	 	 	Facsimile: 203-798-3601

	15.5	 	The relationship of Diosynth to BIODEL established by this Agreement is that of an
independent contractor. Nothing contained in this Agreement shall be construed to constitute
Diosynth as a partner, agent or joint venturer with BIODEL or as a participant in a joint or
common undertaking with BIODEL.

	15.6	 	Neither party shall without the prior written consent of the other party refer to the other
party in any promotional material.
	 
	15.7	 	This Agreement and its Appendices set forth the entire agreement between the parties
concerning the subject matter hereof and supersedes all written or oral prior agreements or
understandings with respect thereto. Neither party’s general conditions of sale or purchase
shall be applicable.

AS AGREED UPON and signed in duplicate by authorized representatives of each party at

	 	 	 	 	 	 	 	 	 
	Oss,	 	 	 	 	 	Danbury,
	Diosynth BV	 	 	 	Biodel Inc.
	 
	 	 	 	 	 	 	 	 
	/s/

	 	A. Sanders
	 	 	 	/s/
	 	Solomon S. Steiner
	 
	 	 	 	 	 	 	 	 
	 	 	 	 	 
	By:

	 	Adriaan Sanders
	 	 	 	By:
	 	Solomon S. Steiner, Ph.D.
	Title:

	 	API Operations Manager
	 	 	 	Title:
	 	Chief Executive Officer
	 
	 	 	 	 	 	 	 	 
	/s/

	 	G. de Lavalette	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 
	By:

	 	Gert Jan Renardel de Lavalette	 	 	 	 	 	 
	Title:

	 	Marketing and
Sales Manager	 	 	 	 	 	 

 

9

APPENDIX A—Page 1 of 3

DIOSYNTH PRODUCT SPECIFICATIONS

[...***...],EX-10.11

 

Exhibit 10.11

***TEXT
OMITTED AND FILED SEPARATELY

CONFIDENTIAL TREATMENT REQUESTED

QUOTATION

ViajectTM [***]

Version 06

Biodel Inc.

(referred to as “Client”)

6 Christopher Columbus Avenue

Danbury, CT 06810

QTE-2005-0299

Date: September 13, 2005

Revised: December 20, 2005

CONFIDENTIAL

Pharmaceutical Technologies and

Services Biotechnology and Sterile

Life Sciences Group

Raleigh, North Carolina

 

 

			
	QTE-2005-0299
	 	Page 2 of 21

Executive Summary

Cardinal Health will manufacture ViajectTM [***] (“Product”) for Client as provided herein.

Section 1. Project Instructions

	1.1	 	Project. For purposes of this Quotation, the products and services to be provided by
Cardinal Health pursuant to this Quotation shall be the “Project.”

	1.2	 	Project Instructions. The Project Instructions applicable to the Project (“Project
Instructions”) are the following:

	 	•	 	This Quotation,

	 	•	 	Cardinal Health’s Standard Operating Procedures in effect at the Facility,

	 	•	 	The Master Batch Record, as approved by both parties.

	1.2	 	Specifications. The Specifications applicable to the Project shall be as set forth in the
Project Instructions (“Specifications”).

Section 2. Scope of Work

	2.1	 	Cardinal Health’s Responsibilities.

	 	2.1.1	 	cGMP Facility. Cardinal Health will provide an establishment which is
designed and built in accordance with applicable US laws, rules and regulations,
including without limitation, applicable current Good Manufacturing Practices

	 	2.1.2	 	Records. Cardinal Health will provide all administration, supervision and
record keeping, as required by applicable law and in accordance with Cardinal Health’s
standard operating procedures and practices.

	 	2.1.3	 	Master Batch Record. Cardinal Health will provide labor and materials for
preparation and approval of the Master Batch Record and any subsequent revisions
thereto.

	 	2.1.4	 	Materials. Cardinal Health will provide the following raw materials:

	 	•	 	The following cGMP released components:

	 	 	 	[***]

	 	•	 	[***]
	 
	 	•	 	Vial labels: Standard Black and White Label
	 
	 	•	 	Carton: Standard Two Pack Carton
	 
	 	•	 	Standard Cardinal Health shippers.

8900 Capital Blvd. • Raleigh, North Carolina 27616

Direct: (919) 871-0607 • Facsimile: (919) 871-0309 • www.cardinal.com/pts

CONFIDENTIAL

 

 

	 	 	 	[***]

	 	•	 	[***]
	 
	 	•	 	Vial labels: Standard Black and White Label
	 
	 	•	 	Carton: Standard Two Pack Carton

	 	•	 	Standard Cardinal Health shippers.

	 	•	 	The following tested and released excipients:

	 	•	 	[***]

	 	2.1.5	 	API Receiving Tests. Cardinal Health will conduct the following API
receiving tests in accordance with the test requirements, methods and specifications
provided and/or approved by Client:
	 
	 	 	 	[***]

	 	•	 	[***]

	 	2.1.6	 	In Process Tests. Cardinal Health will conduct the following in process
tests in accordance with the test requirements, methods and specifications provided
and/or approved by Client:
	 
	 	 	 	[***]

	 	2.1.7	 	Manufacture, Inspection and Packaging. Cardinal Health will provide
manufacture, inspection and packaging, in accordance with a Master Batch Record
approved by the parties, as follows:
	 
	 	 	 	[***]

	 	2.1.8	 	Finished Product Tests. Cardinal Health will conduct the following finished
Product tests in accordance with the test requirements, methods and specifications
provided and/or approved by Client:
	 
	 	 	 	[***]

	 	2.1.9	 	Cleaning. Following batch manufacture, Cardinal Health will clean the
applicable Facilities and Equipment in accordance with Cardinal Health’s standard
operating procedures.

	 	2.1.10	 	Waste Disposal. Cardinal Health will engage a contractor to dispose of all Product
related waste in accordance with applicable laws, rules and regulations.

	 	2.1.11	 	Post-Manufacture Review. Following manufacture of the Product as provided above,
Cardinal Health will review and approve the lot specific batch records prior to
Client’s final release of product.

	 	2.1.12	 	Batch Records. Cardinal Health will provide Client with a copy of each lot specific
Batch Record.

	 	2.1.13	 	Samples. Cardinal Health will maintain up to 10 retention samples, as
requested by Client.

8900 Capital Blvd. • Raleigh, North Carolina 27616

Direct: (919) 871-0607 • Facsimile: (919) 871-0309 • www.cardinal.com/pts

CONFIDENTIAL

 

 

	 	2.1.14	 	Validation Support. Cardinal Health will provide validation support as defined in
the quotation below.

	 	2.1.15	 	Storage. Cardinal Health will store the API and Product in accordance with storage
specifications provided by Client. Cardinal Health will store finished Product for up
to two (2) weeks following finished Product release by Cardinal Health. If Cardinal
Health consents to store the Product for a longer period of time, Cardinal Health will
charge storage fees in accordance with this Quotation and Client will be required to
provide Cardinal Health with a letter confirming the following: (i) Client has made a
fixed commitment to purchase such Product, (ii) risk of ownership for such Product
passes to Client, (iii) such Product shall be on a bill and hold basis for legitimate
business purposes, (iv) if no delivery date is determined at the time of billing,
Cardinal Health shall have the right to ship the Product to Client within four months
after billing, and (v) Client will be responsible for any decrease in market value of
such Product that relates to factors and circumstances outside of Cardinal Health’s
control.

	 	2.1.16	 	Delivery. Cardinal Health will bulk pack the Product using standard Cardinal Health
shippers. These shippers are not validated for Client Product. If requested by
Client or if otherwise necessary, Cardinal Health will palletize the Product for
delivery to Client or its designated recipient. All shipments shall be F.O.B.
Cardinal Health’s shipping docks. If Client has not specifically designated a
preferred carrier, Cardinal Health will select the carrier for shipment.

	2.2	 	Client’s Responsibilities

	 	2.2.1	 	Project Instructions. Client will:

	 	•	 	Provide manufacturing instructions to enable Cardinal Health to prepare the
master batch record.

	 	•	 	Review and approve the master batch record and any subsequent revisions.

	 	•	 	Provide test requirements, specifications, and methods as provided below.

	 	2.2.2	 	Test Requirements, Methods & Specifications. Client will provide (i) test
requirements, (ii) validated or reproducible analytical methods and related
documentation, and (iii) applicable Specifications for the following:

	 	•	 	API Receiving Tests

	 	•	 	Raw Material Testing (as necessary)

	 	•	 	In Process Testing

	 	•	 	Finished Product Testing

	 	2.2.3	 	Materials. Client will supply the following materials and items to Cardinal Health:

	 	•	 	[***]

	 	2.2.4	 	Safety Information. Client will provide all known safety information
relating to the Product, API and other raw materials supplied by Client under this
Quotation, including without limitation Material Safety Data Sheets (“MSDS”)
applicable to each such item.

	 	•	 	[***]

8900 Capital Blvd. • Raleigh, North Carolina 27616

Direct: (919) 871-0607 • Facsimile: (919) 871-0309 • www.cardinal.com/pts

CONFIDENTIAL

 

 

	 	2.2.5	 	Artwork. If Cardinal Health is labeling the Product, Client will provide
approved artwork that meets all applicable regulatory requirements.

	 	2.2.6	 	Samples. Client will maintain all retention samples and stability samples
required by applicable laws, rules and regulations.
	 
	 	2.2.7	 	Cleaning. Client will provide cleaning methods.

Section 3. Pricing

	3.1	 	Project Pricing. All of the pricing stated throughout this quotation is valid through
[***].

Dedicated Equipment

	 	 	 
	[***] Life Sciences Activity	 	Estimated Price
	[***]
	 	 
	 

	 	[***]
	[***]

	 	$ [***]
	Vendor Assessment Audit (does not include airfare, travel
and per diem which will be charged at the actual expenses)
	 	 
	•     Requirements Specification
	 	 
	•     21 CFR Assessment, if required

	 	 
	•     [***]

	 	$ [***]
	Subtotal

	 	$ TBD

[***]

Method Transfers and Validation*

	 	 	 	 	 
	[***] Life Sciences Activity	 	Price	 	Deliverable/Other Comments
	[***]

	 	$ [***]
	 	Report
	[***]

	 	$ [***]
	 	Report
	[***]

	 	$ [***]
	 	Report
	[***]

	 	$ [***]
	 	Report
	[***]

	 	$ [***]
	 	Report
	Subtotal

	 	$ [***]	 	 

[***]

Project Initiation Costs

	 	 	 	 	 
	[***] Life Sciences Activity	 	Price	 	Deliverable/Other Comments
	Creation of [***] and associated records per [***].

	 	$ [***]
	 	Approved documents
	Includes:
	 	 	 	 
	•     Master Batch Record
	 	 	 	 
	•     Sample Schedule
	 	 	 	 
	•     Analytical Methods and Specifications
	 	 	 	 
	•     [***]
	 	 	 	 
	•     Component Specifications
	 	 	 	 
	[***]

	 	$ [***]
	 	Approved documentation
	[***] and Approvals

	 	$ [***]	 	 
	[***] and Approvals

	 	$ [***]	 	 
	Subtotal

	 	$ [***]	 	 

8900 Capital Blvd. • Raleigh, North Carolina 27616

Direct: (919) 871-0607 • Facsimile: (919) 871-0309 • www.cardinal.com/pts

CONFIDENTIAL

 

 

[***]

Technology Transfer, [***]

	 	 	 	 	 
	[***] Life Sciences Activity	 	Price	 	Deliverable/Other Comments
	[***] Batch(es)
	 	$ [***]	 	[***]
	Manufacture up to [***] of finished drug product.
	 	Per batch	 	 
	Includes:
	 	 	 	 
	•     [***]
	 	 	 	 
	Process Validation: [***]
	 	$ [***]	 	 
	Includes:
	 	$ [***]	 	 
	     [***]
	 	$ [***]	 	 
	 
	 	$ [***]	 	 
	     
	 	 	 	 
	[***]
	 	$ [***]
	 	[***]
	 

	 	$ [***]
	 	
	 

	 	$ [***]
	 	
	 

	 	$ [***]
	 	
	                                                       
	 

	 	 	 	 
	                                                        

[***]

Technology Transfer, [***]

	 	 	 	 	 
	[***] Life Sciences Activity	 	Price	 	Deliverable/Other Comments
	 
	 	$ [***]
	 	[***]
	[***] Batch(es)
	 	 	 	 
	Manufacture up to [***] of finished drug product.
	 	 	 	 
	[***]

	 	$ [***]
	 	[***]
	Process Validation: [***]

	 	$ [***]
	 	
	Includes

	 	$ [***]
	 	
	[***]

	 	$ [***]
	 	
	 
	 	$ [***]
	 	[***]
	 

	 	$ [***]
	 	
	 

	 	$ [***]
	 	
	 

	 	$ [***]
	 	
	                                                       
	 

	 	 	 	 
	                                                        

Validations*

	 	 	 	 	 
	[***] Life Sciences Activity	 	Price	 	Deliverable/Other Comments
	[***]

	 	$ [***] per
	 	[***]
	 

	 	formulation
	 	
	 

	 	 	 	

 

 

	 	 	 	 	 
	 

	 	$ [***]	 	 
	 
	 	 	 	 
	 

	 	$ [***]	 	 
	 
	 	 	 	 
	 

	 	$ [***]	 	 
	 
	 	 	 	 
	[***],
if required
	 	$ [***]
	 	Report
	
	 	$ [***]
	 	Report
	Includes:
	 	 	 	 
	•     [***]
	 	 	 	 
	[***]

	 	$ [***]
	 	Report
	Includes:

	 		 	
	•     [***]
	 	 	 	 
	       [***]
	 	 	 	 
	[***], if required

	 	$ [***]
	 	Report
	[***], if required
	 	$ [***]
	 	Report
	Includes:
	 	 	 	 
	•     [***]

	 
	[***], if required

	 	$ [***]
	 	Report
	[***], if required

	 	$ [***]
	 	Report
	[***], if required

	 	$ [***]	 	 

*[***]

Regulatory

	 	 	 	 	 
	[***] Life Sciences Activity	 	Price	 	Deliverable/Other Comments
	[***]

	 	$ [***]
	 	Report
	

	 	$ [***]
	 	
	 
	 	 	 	 
	Regulatory Assistance/Consulting

	 	 	 	$[***] to $[***] per hour
depending on the
personnel utilized

[***] Studies

VIAJECTTM Release and [***] Study ([***])

Cardinal Health will perform release analysis and conduct a [***] study, including storage and
analysis, on [***] lots of
VIAJECTTM drug product [***]. It is assumed that the release
analysis will constitute the initial interval of the [***] study.

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	[***]	 	[***]	 	Interval [***]
	 	 	 	 	 	 	[***]	 	[***]	 	[***]	 	[***]	 	[**]	 	[***]	 	[***]	 	[***]
	[**]
	 	 	—	 	 	 	[**]	 	 	 	—	 	 	 	—	 	 	 	—	 	 	 	—	 	 	 	—	 	 	 	—	 	 	 	—	 
	[**]
	 	 	[**]	 	 	 	—	 	 	 	 	 	 	 	[**]	 	 	 	[**]	 	 	 	[**]	 	 	 	[**]	 	 	 	[**]	 	 	 	[**]	 
	 
	 	 	[**]	 	 	 	—	 	 	 	[**]	 	 	 	[**]	 	 	 	[**]	 	 	 	[**]	 	 	 	[**]	 	 	 	[**]	 	 	 	[**]	 
	[**]
	 	 	[**]	 	 	 	—	 	 	 	[**]	 	 	 	[**]	 	 	 	[**]	 	 	 	—	 	 	 	—	 	 	 	—	 	 	 	—	 
	 
	 	 	[**]	 	 	 	—	 	 	 	[**]	 	 	 	[**]	 	 	 	[**]	 	 	 	—	 	 	 	—	 	 	 	—	 	 	 	—	 

[***]

Total Estimated [***] Study Cost ([***])

	 	 	 	 	 
	Interval	 	Activity	 	Estimated Cost ($)4
	[***]
	 	[***]
	 	[***]

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	[***]
	 	[***]
	 	[***]
	[***]
	 	[***]
	 	[***]
	[***]
	 	[***]
	 	[***]
	[***]
	 	[***]
	 	[***]
	[***]
	 	[***]
	 	[***]
	[***]
	 	[***]
	 	[***]
	[***]
	 	[***]
	 	[***]
	[***]
	 	 
	Total Estimated [***] Study Cost
	 	 
	([***])
	 	[***]

VIAJECTTM [***] Study ([***])

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	[**]	 	[**]	 	Interval [**]
	 	 	 	 	 	 	[**]	 	[**]	 	[**]	 	[**]	 	[**]	 	[**]	 	[**]	 	[**]
	[**]
	 	 	—	 	 	 	[**]	 	 	 	—	 	 	 	—	 	 	 	—	 	 	 	—	 	 	 	—	 	 	 	—	 	 	 	—	 
	[**]
	 	 	[**]	 	 	 	—	 	 	 	[***]	 	 	 	[**]	 	 	 	[**]	 	 	 	[**]	 	 	 	[**]	 	 	 	[**]	 	 	 	[**]	 
	[**]
	 	 	[**]	 	 	 	—	 	 	 	[**]	 	 	 	[**]	 	 	 	[**]	 	 	 	[**]	 	 	 	[**]	 	 	 	[**]	 	 	 	[**]	 
	
	
	
	

	
	
	
	

	
	
	
	

	
	
	
	

	[***]
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 

Total Estimated [***] Study Costs

	 	 	 
	Corresponding [***] Interval at which the [***] Studies are	 	Total [***] Studies Cost
	Initiated	 	([***]) ($)[***]
	[***]
	 	[***]
	[***]
	 	[***]
	[***]
	 	[***]
	[***]
	 	[***]
	[***]
	 	[***]
	[***]
	 	[***]
	Total Estimated Cost for [***] Studies ([***])
	 	[***]

Ad Hoc Analyses Costs

	 	 	 
	Activity	 	Cost per Analysis
	[***]
	 	[***]
	[***]
	 	[***]
	[***]
	 	[***]
	[***]
	 	[***] for the first sample/[***] or each additional sample
	[***]
	 	[***]for first sample/[***] or each additional sample
	[***]
	 	[***]
	[***]
	 	[***]
	[***]
	 	[***]

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[***]

VIAJECTTM [***] Study ([***]; Controlled and Exposed Samples)

	 	 	 	 	 
	Storage Condition	 	Interval [***]
	 
	 	[***]	 	[***]
	[***]	 	[***]
	 	—
	[***]	 	—	 	[***]

[***]

Total Estimated [***] Study Cost ([***])

	 	 	 	 	 
	Interval	 	Activity	 	Estimated Cost
	[***]	 	—	 	—
	[***]	 	[***]	 	[***]
	[***]
	 	[***]
	Total Estimated [***] Study Cost ([***])
	 	[***]

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Additional Fees

	 	 	 
	Activity	 	Price
	Out-of-Specification Investigations

	 	Cardinal Health will conduct
Out-of-specification (OOS) investigations,
without prior approval from the Client. All OOS
investigations will be reviewed and approved by
the Client and Cardinal Health. If an OOS
investigation indicates that Cardinal Health is
responsible for the OOS result, Cardinal Health
will not charge Client for the investigation
cost. If an OOS investigation does not indicate
that Cardinal Health is responsible for the
assignable cause of an OOS result, the cost of
the investigation will be invoiced to Client at
$[***]/hour.
	 
	 	 
	Consulting/Assistance of
development, technical and
engineering staff including, but
not limited to Product manufacture
support, telephone consultation
and meetings.

	 	Billed at $[***] to $[***] per hour depending on
the person involved, plus materials.
	 
	 	 
	Cardinal Health’s reasonable
travel costs will be billed at
Cardinal Health’s actual cost and
shall include airfare, hotel,
transportation, and per diem.

	 	To Be Determined, per trip
	 
	 	 
	Miscellaneous Dedicated Equipment
& Supplies — Tanks, HPLC Columns,
etc. if required

	 	Vendor cost to Cardinal Health plus shipping,
handling and [***] handling fee.
	 
	 	 
	Shipping

	 	All Product and samples are shipped FOB Cardinal
Health’s WAREHOUSE.
	 
	 	 
	Product Storage

	 	[***]
	 
	 	 
	Charges for Cancellation or
Postponement of Batch Manufacture

	 	The Fee for cancellation or postponement of a
batch shall be the greater of (i) total time and
materials expended up to date of cancellation or
postponement or (ii) a percentage of the total
batch fee as follows:

	 	 	 
	Notification prior to fill date	 	 
	as agreed by both parties	 	Percentage of batch fee
	30 to 60 days

	 	[***]
	15 to 29 days

	 	[***]
	8 to 14 days

	 	[***]
	Less than 8 days

	 	[***]

	 	 	 
	 

	 	Client will not be allowed to postpone a batch
more than 30 days prior to filling the batch.
	 
	 	 
	Charges for Cancellation or
Postponement of services other
than Batch Manufacture

	 	[***]

	3.2	 	Revisions to Pricing. In addition to any reasons for price changes expressly set forth in
Exhibit 1, Cardinal Health may revise the prices provided in this Quotation if reasonably
unforeseeable circumstances affect the work required to complete the Project. Cardinal Health
will notify Client immediately if the costs to complete the Project exceed the prices stated
in this Quotation. Cardinal Health will not commence work involving charges in

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	 	 	excess of those stated in this Quotation
without Client approval unless such
advance notice was not possible due to the
circumstances.

Section 4. Scheduling Policy

Cardinal Health will work closely with you to ensure that your requirements are met;
however, in order for Cardinal Health to maintain a smooth R&D/Manufacturing schedule, and
offer maximum flexibility to our Clients without punitive fees, Cardinal Health adheres to
the Scheduling Policy set forth in this Section.

Cardinal Health will not confirm a manufacture date or project start date until Cardinal
Health receives the signed Proposal Acceptance Sheet attached to this Quotation, and a
Purchase Order referring to this Quotation. In the event Cardinal Health does schedule a
manufacture date or project start date without a signed Proposal Acceptance Sheet or
Purchase Order, Cardinal Health may reschedule the manufacture start date or Project Start
Date without notice to the Client.

IMPORTANT: Client must also provide the information or take the actions, as appropriate,
specified in the following chart, by the time specified in the chart:

Action Item Table — Items outlined below assume a finalized project scope and plan as
agreed upon by both Cardinal Health and Client.

	 	 	 
	Action Items	 	Due Date
	Client provide Cardinal Health with signed Proposal
Acceptance Sheet and Purchase Order

	 	Prior to scheduling the
manufacture start date or project
start date
	[***]

	 	[***]
	[***]

	 	[***]
	[***]

	 	[***]
	Client provide all information required to
manufacture the product

	 	6 weeks prior to the scheduled
manufacture date
	Such information shall include, but not be limited to:
	 	 
	•     Manufacturing Instructions
	 	 
	•     Raw Material, In-process and finished product
test tests, methods, and specifications
	 	 
	•     MSDS
	 	 
	•     Cleaning procedures
	 	 
	•     Shipping procedures
	 	 
	HPLC Columns, Standard, API or raw material samples 

for method transfer

	 	6 weeks prior to the scheduled
manufacture date
	Client provide dedicated, process specific or other 

equipment required for development or manufacture

	 	TBD with project manager
	Client provide as applicable, API, raw materials,
components, Certificates of Analysis, HPLC columns,
standards and related items as specified in the Scope
of Work

	 	6 weeks prior to manufacture start
date
	Cardinal Health to complete methods transfer and
validation

	 	[***]
	Cardinal Health to provide client Master Batch Record
for Review

	 	4 weeks prior to scheduled
manufacture date
	Client to review Master Batch Record and comment

	 	3 weeks prior to scheduled
manufacture date

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	Action Items	 	Due Date
	Client to provide sample requirements

	 	2 weeks prior to scheduled
manufacture date
	Client to approve Master Batch Record, and all
subsequent revisions

	 	At least 2 weeks prior to
manufacture start date or project
start date
	Client to approve art work for labeling and packaging

	 	4 weeks prior to scheduled
manufacture date
	Client to approve Packaging Batch Record

	 	1 week prior to product manufacture
	Client to provide shipping instructions (destination)

	 	2 weeks after lot manufacture

The time frames provided in the Action Item Table are necessary to ensure that all
departments are properly informed and trained regarding their responsibilities for the
Project. Client’s failure to complete any of the Action Items by the Due Date specified in
the Action Item Table will result in a rescheduling of the manufacture start date or
project start date by at least the number of days by which Client was late in completing
the action item. In addition, certain delays may result in additional charges as
determined in the discretion of Cardinal Health.

Cardinal Health’s R&D/Manufacturing schedule is necessarily complex, and Cardinal Health
reserves the right to change the schedule to permit maximum utilization of its facilities.
Should scheduling changes be necessary, you will be notified immediately by your project
manager or coordinator.

Section 5. Terms and Conditions

	5.1	 	Standard Terms and Conditions. The Standard Terms and Conditions attached to this
Quotation as Exhibit 1 are an integral part of this Quotation and are incorporated herein by
reference. In the event of a conflict between the terms of this Quotation and the attached
Standard Terms and Conditions, the Standard Terms and Conditions shall govern. In the event
of a conflict between the terms and conditions of this Quotation and any purchase order or
other documentation submitted by Client, this Quotation shall govern.

	5.2	 	Invoicing and Payment Terms. Cardinal Health will invoice for batch manufacture upon the
earlier of (i) release of the batch by Cardinal Health, or (ii) thirty-five (35) days
following shipment of samples to a third party for testing, if test results are not completed
by such time. For all work other than batch manufacture, Cardinal Health will invoice upon
completion of the work, unless the work is to take longer than four weeks, in which case,
Cardinal Health will invoice on a monthly basis for work performed in the preceding month.
Client shall pay each invoice within 45 days of receipt.
	 
	5.3	 	Initial Batches. [***]

	5.4	 	Unlabeled Product. If Cardinal Health is to provide Client with Product which is not
labeled, Client represents and warrants that it will comply with all applicable regulations,
including without limitation 21 CFR § 201.150.

	5.5	 	Termination. Client may terminate this Quotation upon 15 days notice, subject to payment of
any cancellation fees as provided in Section 3. Either party may terminate this Quotation:
(i) effective upon sixty (60) days prior written notice to the other party, if the other party
commits a material breach of this Quotation and fails to cure such breach by the end of such
sixty (60) day period; provided, however, that failure to pay amounts due under this Quotation
within fifteen (15) days after such payments are due shall

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	 	 	constitute cause for immediate termination of this Quotation, or at Cardinal Health’s
discretion, Cardinal Health shall be relieved of any further obligation to perform under
this Quotation until all outstanding payments are brought current, or (ii) effective upon
written notice to the other party, if the other party becomes insolvent or admits in
writing its inability to pay its debts as they become due, files a petition for bankruptcy,
makes an assignment for the benefit of its creditors or has a receiver, trustee or other
court officer appointed for its properties or assets.

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Project Approval and Authorization

Completion of this Project Approval and Authorization page signifies the Client’s acceptance of
this Quotation and the terms and conditions, including without limitation the Standard Terms and
Conditions attached to this Quotation as Exhibit 1. If you have not received a copy of the
Standard Terms and Conditions, please request a copy as they are an integral part of this
Quotation.

	 	 	 
	Biodel Inc.

	 	Cardinal Health PTS, LLC
	 
	 	 
	/s/ Solomon S. Steiner

	 	/s/ Charles M. Proby
	 

	 	 
	Signature

	 	Signature
	 
	 	 
	Solomon S. Steiner

	 	Charles M. Proby
	 

	 	 
	Printed Name

	 	Printed Name
	 
	 	 
	Chairman and CEO

	 	Vice President, Business Development
	 

	 	 
	Title

	 	Title
	 
	 	 
	December 31, 2005

	 	December 1, 2005
	 

	 	 
	Date

	 	Date

PLEASE NOTE: The Acceptance Sheet must be signed by Client and delivered to Cardinal Health
along with a Purchase Order before Cardinal Health will schedule services and allocate resources.
If the Acceptance Sheet is incomplete when submitted (i.e., Accounts Payable contract information,
required payment or approval signature, etc.), and/or a Purchase Order is not submitted, delays in
scheduling will result.

All invoicing is to be sent directly to:

	 	 	 	 	 
	Name:

	 	 	 	 
	 

	 	 	 	 
	Department:
	 	 	 	 
	 

	 	 	 	 
	Telephone No.:
	 	 	 	 
	 

	 	 	 	 
	Address:
	 	 	 	 
	 

	 	 	 	 
	 
	 	 	 	 
	 	 	 

Preferred Initial Payment Method (ü): o Check Enclosed      o Wire Transfer

Any modifications of this Quotation must be made with an approved Change Order.

	 	 	 
	Mail or fax the proposal acceptance sheet to: 

Manufacturing

	 	Cardinal Health PTS, LLC — Contract
	 

	 	Attention: Renée Toy
	 

	 	4401 Alexander Blvd. NE
	 

	 	Albuquerque, NM 87107
	 

	 	(505) 923-1431 (fax)

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	Wire payment to:	 	Overnight mail payment to:	 	Regular mail payment to:
	Bank:

City/State:

ABA #:

Account #:

FBO:

Ref:

	 	First Union Bank

Charlotte, NC

053000219

2000002932213

Cardinal Health, Inc.

Cardinal Health PTS, LLC
	 	PNC Bank

1200 E. Campbell Road

Box #676457

Richardson, TX 75081

505-923-1251 (phone)
	 	Cardinal Health PTS, LLC

P.O. Box 676457

Dallas, TX 75267-6457

A. Quotation Expiration. This Quotation is valid for thirty (30) days from the date of the
Quotation, unless extended by Cardinal Health.

B. Audits. Client may conduct one quality assurance facility audit per year at no cost.
Additional audits will be invoiced separately at the current rate for such services.

C. Regulatory Inspections. Cardinal Health will promptly notify Client of any regulatory
inspections directly relating to the Project and/or any facility in which the Product is
manufactured, which is likely to impact the Product. Client accepts reasonable and documented costs charged by a regulatory authority for
inspections directly related to the Project.

D. Price Changes. Cardinal Health may revise the prices provided in this Quotation if (i)
Client’s requirements or any Client-provided information is inaccurate or incomplete, (ii) Client
revises Cardinal Health’s responsibilities, the Specifications, the Project Instructions,
procedures, assumptions, processes, test protocols, test methods or analytical requirements, to the
extent applicable to the Project, or (iii) for such other reasons set forth in the Quotation. No
increase in price shall be effective until approved by Client in writing.

E. Payments. Cardinal Health will invoice Client as set forth in the Quotation. Cardinal
Health charges a late payment fee of 11/2% per month for undisputed payments not received within
forty-five (45) days after receipt of Cardinal Health’s invoice. Failure to bill for interest due
shall not be a waiver of Cardinal Health’s right to charge interest. Client shall pay Cardinal
Health for each order within forty-five (45) days after receipt of Cardinal Health’s invoice.
Cardinal Health will issue invoices upon release by Cardinal Health.

F. Taxes. Client will pay any sales, use or any like tax (excluding taxes based on income)
required to be collected by Cardinal Health from Client by any tax jurisdiction arising from the
transfer of the Product to Client.

G. Hazardous Materials. Client warrants to Cardinal Health that no specific safe handling
instructions are applicable to any substance or material provided by Client to Cardinal Health,
except as disclosed to Cardinal Health in writing by the Client in sufficient time for review and
training by Cardinal Health prior to delivery. Where appropriate or required by law, Client will
provide a Material Safety Data Sheet for all Client-provided materials, finished Product, and
reference standards.

H. Shipment. Unless otherwise specified in the Quotation, all product, raw materials and
components shipped by Cardinal Health are delivered F.O.B. Cardinal Health’s facilities. Client
shall make all arrangements, including arrangements for insurance and payment terms, with a carrier
to transport items from Cardinal Health’s facility under this Agreement. All Products shall be
deemed delivered and subject to Client’s dominion and control when placed in the possession of the
carrier, packed and ready for shipment. Except as provided in Section I, all risk of loss or
damage to the Products from any cause whatsoever shall be borne by Cardinal Health until delivery
of the Products to, and acceptance by, the carrier at the FOB point, at which time title and risk
of loss shall transfer to Client. Cardinal Health shall cooperate with Client in the

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documentation and proof of loss claims promptly presented by Client to the appropriate carrier
and/or insurer. Cardinal Health will pack and ship Products in accordance with the Specifications.
Costs of packing for shipments of Products made under this Quotation are included in the agreed
prices.

I.A. Limitations of Liability. IN NO EVENT SHALL EITHER PARTY BE LIABLE TO THE OTHER PARTY
FOR ANY SPECIAL, CONSEQUENTIAL, EXEMPLARY OR INCIDENTAL DAMAGES, WHETHER OR NOT FORESEEABLE,
ARISING FROM THE PROJECT OR THIS QUOTATION; provided, that nothing contained herein shall limit
Cardinal Health’s or Client’s obligation to indemnify the other Party under Section N for actions
brought by third parties, even if such actions include claims by third parties for special,
consequential, indirect, incidental or punitive damages.

I.B. EXCEPT TO THE EXTENT CAUSED BY CARDINAL HEALTH’S GROSS NEGLIGENCE OR WILLFUL MISCONDUCT,
CARDINAL HEALTH’S TOTAL LIABILITY UNDER THIS QUOTATION FOR ANY AND ALL CLAIMS FOR LOST, DAMAGED, OR
DESTROYED API OR CLIENT-SUPPLIED MATERIALS WHETHER OR NOT SUCH API OR CLIENT-SUPPLIED MATERIALS ARE
INCORPORATED INTO FINISHED PRODUCT SHALL NOT EXCEED $ [***] PER OCCURRENCE.

IC. EXCEPT TO THE EXTENT
CAUSED BY CARDINAL HEALTH’S GROSS NEGLIGENCE OR WILLFUL MISCONDUCT,
CARDINAL HEALTH’S TOTAL CUMULATIVE LIABILITY UNDER THIS QUOTATION FOR LOSSES ARISING DURING ANY
CONTRACT YEAR SHALL IN NO EVENT EXCEED THE TOTAL FEES PAID UNDER THIS QUOTATION BY CLIENT DURING
SUCH CONTRACT YEAR.

J.A. Confidentiality. All information and materials disclosed or provided by a party in
connection with this Quotation shall be confidential information, unless such information is (1)
already known to the receiving party, as evidenced by written records; (2) independently developed
or discovered by the receiving party without the use of the disclosing party’s confidential
information, as evidenced by written records; (3) in the public domain other than through the fault
of the receiving party; or (4) disclosed to the receiving party by a third party not in breach of a
duty of confidentiality owed to the disclosing party. Neither party shall, without the other
party’s prior written consent, use the confidential information of the other party or disclose such
information to anyone other than employees of the receiving party or its affiliated entities who
require such information to perform such party’s obligations under this Quotation. Notwithstanding
the foregoing, either party may disclose any Confidential Information of the other party to the
extent such Confidential Information is required to be disclosed by law, or court or administrative
order; provided, that the receiving party first gives prompt notice thereof to the
disclosing party and a reasonable opportunity to contest such disclosure. This undertaking shall
survive for 7 years following termination of this Quotation. Each party hereby acknowledges and
agrees that in the event of its breach of this Quotation, including, without limitation, the actual
or threatened disclosure of the disclosing party’s Confidential Information without the prior
express written consent of the disclosing party, the disclosing party will suffer an irreparable
injury, such that no remedy at law will afford it adequate protection against, or appropriate
compensation for, such injury. Accordingly, each party hereby agrees that the disclosing party
shall be entitled to specific performance of the receiving party’s obligations under Sections JA,
JB and JC, as well as such further injunctive relief (without need to post a bond) as may be
granted by a court of competent jurisdiction.

JB. Further Exception. Notwithstanding the foregoing, a party may disclose Confidential
Information of the other party (a) to its attorneys, accountants and other professional advisors
under an obligation of confidentiality to the other party, (b) to banks or other financial
institutions or venture capital sources for the purpose of raising capital or borrowing money or
maintaining

 

 

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CONFIDENTIAL

compliance with agreements, arrangements and understandings relating thereto, provided that such
party uses good faith efforts to obtain an agreement to maintain such information in
confidentiality and only discloses those limited pieces of Confidential Information which are
required to be disclosed for such purposes, and (c) to any person who proposes to purchase or
otherwise succeed (by merger, operation of law or otherwise) to all of a party’s right, title and
interest in, to and under this Quotation, if such person agrees to maintain the confidentiality of
such Confidential Information pursuant to a written agreement in form and substance reasonably
satisfactory to the parties. The standard of care required to be observed hereunder shall be not
less than the degree of care which a party uses to protect its own information of a confidential
nature.

JC. Non-Use of Names. Neither party shall use the name of the other party nor the name of
any of Affiliates or employees of such other party, nor any adaptation thereof, in any press
release, advertising, promotional or sales literature without the prior written consent of such
other party in each case.

K.A. Intellectual Property. All Cardinal Health Materials, including without limitation,
all improvements, developments, derivatives or modifications to the Cardinal Health Materials,
shall be owned exclusively by Cardinal Health. All Client Materials, including, without
limitation, all improvements, developments, derivatives or modifications to the Client Materials
shall be owned exclusively by Client. For purposes hereof, “Cardinal Health Materials” means all
Cardinal Health proprietary information, intellectual property, and developments, including without
limitation, all patents, patent applications, know-how, inventions, designs, concepts,
improvements, technical information, manuals, instructions or specifications, which are owned,
licensed or used by Cardinal Health in developing, formulating, manufacturing, filling, processing
(sterile or non-sterile), packaging, analysis or testing pharmaceutical products and the packaging
equipment, processes or methods of packaging, or any improvements to any of the foregoing. For
purposes hereof, “Client Materials” means all proprietary information, intellectual property, and
developments, including without limitation, all patents, patent applications, know-how, inventions,
designs, concepts, improvements, technical information, manuals, instructions or specifications,
which are owned, licensed or used by Client relating to Client’s Product or the formulation
thereof. Notwithstanding the foregoing, any improvements or modifications that are specific to the
Products and/or the processes or methods for the manufacture of the Products and the intellectual
property relating thereto that are discovered or developed by Cardinal Health and/or Client in the
performance of the Project shall be owned solely by Client. Cardinal Health shall hold all such
improvements and modifications in confidence for Client’s sole benefit in the development and/or
the operation of manufacturing processes with respect to the Products. Cardinal Health shall
disclose to Client and receive the approval of Client with respect to all such improvements or
modifications developed by Cardinal Health. For the avoidance of doubt, Cardinal Health shall own
developments (and related intellectual property) in the manufacturing processes, systems or methods
used by Cardinal Health to manufacture Products under this Quotation made by Cardinal Health in the
performance of the Project that have applicability to the Product or Project but that have
applicability to other products as well; provided Cardinal Health hereby grants to Client and its
designated contract manufacturers a non-exclusive, world-wide, royalty-free, non-revocable license
under such developments and related intellectual property to make, use and sell the Products, this
license to survive termination of this Quotation. Cardinal Health shall have no right or license
to use any intellectual property relating to the Products at any time before, during or after the
term of this Quotation, except as necessary for the manufacture, processing, packaging and supply
of the Products to Client hereunder. To the extent that the manufacture of the Products by a third
party using manufacturing processes, systems or methods used by Cardinal Health to manufacture
Products under this Quotation would infringe any intellectual property of Cardinal Health, Cardinal
Health hereby grants to Client and its designated contract manufacturers a non-exclusive,
world-wide, royalty-free, non-

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revocable license under such intellectual property to make, use and sell the Products, this license
to survive termination of this Quotation.

KB. Reproduction of Trademarks. In connection with Cardinal Health’s performance of this
Quotation, Client hereby grants Cardinal Health the right to reproduce and print on the Products
Client trademarks, trade dress and/or trade names of any such Products which Client may designate
in writing from time to time, in accordance with trademark usage guidelines set forth in the
Specifications or otherwise provided by Client. Samples of all such uses of such trademarks and/or
trade names on any Products or Products packaging shall be submitted to Client for its written
approval prior to production. The permission granted herein is restricted to the Products supplied
under this Quotation and extends only for the term of this Quotation.

KC. Cardinal Health’s Limited Rights to Use. Nothing set forth in this Quotation shall be
construed to grant to Cardinal Health any title, right or interest in or to any intellectual
property owned by Client, or any of its affiliates, or to which Client, or any of its affiliates,
may have rights. Cardinal Health’s use of such intellectual property shall be limited exclusively
to its performance of this Quotation.

L. Warranties. Cardinal Health represents and warrants to Client (a) that Products supplied
to Client, pursuant to this Quotation shall be free of any lien, charge, encumbrance and interest
of any nature whatsoever of any third party, and (b) that Cardinal Health will perform the Project
and manufacture the Product in accordance with the Specifications, Project Instructions and United
States current Good Manufacturing Practices or current Good Laboratory Practices, as applicable.
THE WARRANTIES SET FORTH IN THE QUOTATION AND THESE STANDARD TERMS AND CONDITIONS ARE THE SOLE AND
EXCLUSIVE WARRANTIES MADE BY CARDINAL HEALTH TO CLIENT AND THERE ARE NO OTHER WARRANTIES,
REPRESENTATIONS OR GUARANTEES OF ANY KIND WHATSOEVER, EITHER EXPRESS OR IMPLIED, REGARDING THE
PRODUCTS OR PROJECT, INCLUDING WITHOUT LIMITATION ANY EXPRESS OR IMPLIED WARRANTIES OF
MERCHANTABILITY, NONINFRINGEMENT OR FITNESS FOR A PARTICULAR PURPOSE.

M. Client Obligations. Unless otherwise agreed to by the parties in writing, Client is
solely responsible to (i) provide complete and accurate scientific data regarding the Project, (ii)
if applicable, review and approve all in-process and finished product test results to ensure
conformity of such results with the product Specifications, regardless of which party is
responsible for finished product release, (iii) prepare all submissions to regulatory authorities,
and (iv) perform such other obligations of Client set forth in the Quotation.

N.A. Client Indemnification. Client will indemnify and hold harmless Cardinal Health, its
affiliates and their officers, directors, agents and employees (each a “Cardinal Health Indemnified
Party”) against any losses incurred by a Cardinal Health Indemnified Party in connection with any
suit, demand or action by any third party arising out of (a) actual or alleged damage to property
or injury or death occurring to any person arising out of possession or use by any person of any
Product, (b) the promotion, or marketing of the Product, (d) negligence or willful misconduct of
Client, (e) breach of this Quotation by Client, or (f) use of any intellectual property provided by
Client to Cardinal Health for performance of this Quotation, except to the extent that any such
losses are due to the gross negligence or intentional misconduct of a Cardinal Health Indemnified
Party or breach of this Quotation by a Cardinal Health Indemnified Party.

NB. Cardinal Health Indemnification. Cardinal Health will indemnify and hold harmless
Client, its affiliates and their officers, directors, agents and employees (each a “Client
Indemnified Party”) against any losses incurred by a Client Indemnified Party in connection with
any suit, demand or action by any third party arising out of (a) any negligence or willful
misconduct by Cardinal

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Health, or (b) Cardinal Health’s breach of this Quotation, except to the extent that any such
losses are due to the gross negligence or intentional misconduct of a Client Indemnified Party or
breach of this Quotation by a Client Indemnified Party.

NC. Procedure. Any person that may be entitled to indemnification under this Quotation (an
“Indemnified Party”) shall give written notice to the person obligated to indemnify it (an
“Indemnifying Party”) with reasonable promptness upon becoming aware of any claim or other facts
upon which a claim for indemnification will be based; the notice shall set forth such information
with respect thereto as is then reasonably available to the Indemnified Party. The Indemnifying
Party shall have the right to undertake the defense of any such claim asserted by a third party
with counsel reasonably satisfactory to the Indemnified Party and the Indemnified Party shall
cooperate in such defense and make available all records, materials and witnesses reasonably
requested by the Indemnifying Party in connection therewith at the Indemnifying Party’s expense.
If the Indemnifying Party shall have assumed the defense of the claim with counsel reasonably
satisfactory to the Indemnified Party, the Indemnifying Party shall not be liable to the
Indemnified Party for any legal or other expenses (other than for reasonable costs of
investigation) subsequently incurred by the Indemnified Party in connection with the defense
thereof. The Indemnifying Party shall not be liable for any claim settled without its consent,
which consent shall not be unreasonably withheld or delayed. The Indemnifying Party shall obtain
the written consent of the Indemnified Party prior to ceasing to defend, settling or otherwise
disposing of any claim. In no event shall Cardinal Health institute, settle or otherwise resolve
any claim or potential claim, action or proceeding relating to any trademarks or other intellectual
property rights of Client without the prior written consent of Client. The indemnification
obligations set forth in this Section N shall survive the expiration or termination of this
Quotation.

O. [RESERVED]

P. Force Majeure. Neither party will be liable for any failure to perform or for delay in
performance resulting from any cause beyond its reasonable control, including without limitation,
acts of God, fires, floods, or weather; strikes or lockouts, factory shutdowns, embargoes, wars,
hostilities or riots, shortages in transportation; provided, however, that if Cardinal Health
cannot complete an order within ninety (90) days due to any such cause, Client may terminate this
Quotation without liability to Cardinal Health and further provided, however, that the Party
claiming that “force majeure” has affected its performance shall give timely notice to the other
Party of becoming aware of the occurrence of force majeure, giving full particulars of the cause or
event and the date of first occurrence thereof. The Party claiming “force majeure” shall use
commercially reasonable efforts to eliminate or prevent the cause so as to continue performing its
obligations under this Quotation.

Q. Use and Disposal. Client represents and warrants to Cardinal Health that Client will
hold, use and/or dispose of Product and materials provided by Cardinal Health in accordance with
all applicable laws, rules and regulations.

R. Record Retention. Unless the parties otherwise agree in writing, Cardinal Health will
retain batch, laboratory and other technical records for the minimum period required by applicable
law.

S. Independent Contractor. It is expressly agreed that Cardinal Health and Client shall be
independent contractors and that the relationship between the two parties shall not constitute a
partnership, joint venture or agency.

T. Publicity. Neither party will make any press release or public disclosure regarding this
Quotation or the transactions contemplated hereby without the other party’s express prior written

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consent, except as required by applicable law or by any governmental agency, in which case the
party required to make the press release or public disclosure shall use commercially reasonable
efforts to obtain the approval of the other party as to the form, nature and extent of the press
release or public disclosure prior to making the public disclosure.

U. Authority. Client grants Cardinal Health full authority to use any Client supplied
materials or substances. Client and Cardinal Health each represent and warrant that it has taken
all necessary action on its part to authorize the execution and delivery of this Quotation and this
Quotation has been duly executed and delivered on behalf of such party, and constitutes a legal,
valid, binding obligation, enforceable against such party in accordance with its terms.

V. Amendment & Precedence. Except for any confidentiality agreement that shall continue to
govern disclosures made pursuant thereto, this Quotation constitutes the entire agreement of the
parties related to the Project and may not be modified without the other party’s prior written
consent. These Standard Terms and Conditions supercede any conflicting terms and conditions set
forth in the Quotation. Any previous written acknowledgement, statement or prior understanding
between the parties related to the Project is superceded by this Quotation.

W. Dispute Resolution. Notwithstanding the place where this Quotation may be executed by
any of the parties hereto, all of the terms and provisions hereof shall be construed in accordance
with and governed by the laws of the State of New York, without giving effect to its conflict of
laws principles. If a dispute arises between the parties in connection with this Quotation, the
respective presidents or Senior Executives of Cardinal Health and Client shall first attempt to
resolve the dispute. If such parties cannot resolve the dispute, such Dispute shall be resolved in
New York City by binding arbitration in accordance with the then existing commercial arbitration
rules of The CPR Institute for Dispute Resolution, 366 Madison Avenue, New York, NY 10017.

X. Survival. Cardinal Health shall use commercially reasonable efforts to return raw
materials in inventory to its suppliers; any raw materials that Cardinal Health cannot return or
which Cardinal Health cannot use in other products shall be purchased by Client from Cardinal
Health at Cardinal Health’s cost. Client shall also reimburse Cardinal Health for any restocking
charges paid by Cardinal Health on account of any returned raw materials. Client shall remove such
inventories of products and raw materials and all packaging, molds and tooling and other Client’s
property in its possession or control of Cardinal Health at its own cost and expense within thirty
(30) days following termination. The provisions of this Section X are in addition to any other
rights or remedies of Client under this Quotation or available under applicable law. The
provisions of these Standard Terms and Conditions relating to confidentiality, intellectual
property, limitations of liability, publicity, non-use of names, indemnity and dispute resolution
shall survive termination or expiration of this Quotation.

Y. Assignment. Neither Party shall assign this Quotation in whole or in part without prior
written consent of the other party; except that either party without prior written consent of the
other party may assign this Quotation in connection with the sale or other disposition of all or
substantially all of its business and assets related to this Quotation. Cardinal Health shall not
delegate, transfer, convey, assign, subcontract or pledge any of its rights or obligations under
this Quotation to any other person, firm, or corporation without the prior written consent of
Client which consent will not be unreasonably withheld or delayed.

Z. No Waiver. The failure of either Party to terminate this Quotation by reason of the
breach of any of its provisions by the other Party, or the failure to exercise any other rights or
remedies

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under this Quotation, will not be construed as a waiver of the rights or remedies available for any
subsequent breach of the terms and provisions of this Quotation.

AA. Severability. The provisions of this Quotation are severable, and the invalidity of
any provision shall not affect; the validity of any other provision.

BB. Expenses. Unless otherwise provided herein, all costs and expenses incurred in
connection with this Quotation and the transactions contemplated hereby shall be paid by the party
that shall have incurred the same and the other party shall have no liability relating thereto.

CC. FDA Cooperation. Client shall own all documents related to the Products filed by
Cardinal Health with the FDA or other regulatory agencies and Client shall be entitled to make
reference to all documents related to the Products and filed by Cardinal Health with the FDA or
other regulatory agencies. The provisions of this Section CC shall survive the termination or
expiration of this Quotation.

DD. Legal and Regulatory Filings and Requests. Cardinal Health and Client shall cooperate
and be diligent in responding to all requests for information from, and in making all required
filings with, regulatory authorities having jurisdiction to make such requests or require such
filings. Cardinal Health shall obtain and comply in all material respects with all licenses,
consents, permits and regulations that may from time to time be required by appropriate legal and
regulatory authorities with respect the performance of its obligations hereunder.

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