Document:

Exhibit 10.1

 

Exhibit 10.1

CERTAIN MATERIAL (INDICATED BY AN ASTERISK) HAS BEEN OMITTED FROM THIS DOCUMENT PURSUANT TO A
REQUEST FOR CONFIDENTIAL TREATMENT. THE OMITTED MATERIAL HAS BEEN FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.

Amendment No. 2 to

Exclusive License Agreement

Between

The Curators of University of Missouri and Santarus, Inc.

     This Amendment No. 2 (the “Amendment”) to the Exclusive License Agreement dated January 26,
2001 and amended as of February 21, 2003 (the “License”), between The Curators of the University of
Missouri (the “University”) and Santarus, Inc. (“Santarus”) is made as of August 20, 2007 (the
“Effective Date”).

RECITALS

     WHEREAS, the University and Santarus desire to amend certain terms of the License as set forth
herein.

AGREEMENT

     NOW, THEREFORE, in consideration of the covenants set forth herein, and for other good and
valuable consideration, the receipt and sufficiency of which is hereby acknowledged, the parties
agree as follows:

     1. Amendment of Section 1.18. Exhibit A is hereby amended to add the
applications set forth in Exhibit A hereto. The University and Santarus agree to
use their best efforts to have the documents in Exhibit B executed and filed with the
United States Patent and Trademark Office. [***].

     2. Amendment of Section 13.3. The parties’ contact information set forth in Section
13.3 of the License is hereby amended as follows:

	 	 	 
	“In the case of Santarus:

	 	Santarus, Inc.

10590 W. Ocean Air Dr., Suite 200

San Diego, CA 92130

Telephone: (858) 314-5700

Facsimile: (858) 314-5701

Attention: President & CEO
	 
	 	 
	with a copy to:

	 	Santarus, Inc.

10590 W. Ocean Air Dr., Suite 200

San Diego, CA 92130

Telephone: (858) 314-5700

Facsimile: (858) 314-5702

Attention: Legal Affairs Department

 

			
	***	 	Certain information on this page has been omitted and filed separately with the Securities and
Exchange Commission. Confidential treatment has been requested with
respect to the omitted portions.

1

 

	 	 	 
	In the case of the University:

	 	University of Missouri

Office of Research

340A Bond Life Sciences Center

Columbia, MO 65211
	 
	 	 
	 

	 	Telephone: 573 884-3553

Facsimile: 573 884-0802

Attention: Michael F. Nichols, Ph.D., Director of

Technology Management & Industry Relations
	 
	 	 
	with a copy to:

	 	University of Missouri

Office of the General Counsel

227 University Hall

Columbia, MO 65211

Telephone: 573-882-3211

Facsimile: 573-882-0050

Attention: Marvin E. Wright, General Counsel
	 
	 	 
	and
	 	 
	 
	 	 
	 

	 	Joseph A. Mahoney

Mayer, Brown, Rowe & Maw LLP

71 South Wacker Drive

Chicago, IL 60606

Telephone: 312-701-8979

Facsimile: 312-706-8530”

     3 Amendment of Section 14.2. Section 14.2 of the License is hereby amended and
restated in its entirety as follows (with the understanding that these changes shall be deemed to
have been effective as of January 26, 2001):

“14.2 All Proprietary Information shall be labeled or marked confidential or
otherwise similarly designated by the disclosing party; provided, however,
that orally or visually disclosed Proprietary Information need not be
reduced to writing or other physical tangible form for such disclosure to be
subject to the confidentiality provisions of Section 14 hereof.
Notwithstanding the foregoing, Santarus and the University may disclose
Proprietary Information to its employees, agents, consultants, contractors,
and, in the case of Santarus, its actual and potential sublicensees,
provided that all such employees, agents, consultants, contractors and
sublicensees are similarly bound by a similar duty of confidentiality.”

     4. Reimbursement for Patent Prosecution Fees. Promptly following the execution of
this Amendment, Santarus will reimburse the University in an amount equal to $[***] for past
prosecution of the patent applications added to Exhibit A pursuant to Section 1 hereof (the
“Additional Patent Rights”) (which $[***] shall consist of payment of Mayer Brown Invoice No.

 

			
	***	 	Certain information on this page has been omitted and filed separately with the Securities and
Exchange Commission. Confidential treatment has been requested with respect to the omitted
portions.

2

 

28516609 in the amount of $[***] and payment of a portion of Mayer Brown Invoice No. 28531712 equal
to $[***]). In addition, the University will diligently prosecute and maintain such Additional
Patent Rights in accordance with Section 11 of the License and Santarus will reimburse the
University for the reasonable costs incurred following the Effective Date for preparing, filing,
prosecuting and maintaining such Additional Patent Rights in accordance with Section 11.5 of the
License. Each of Santarus and the University will bear their own fees and expenses associated
with preparation and negotiation of this Amendment.

     5. Miscellaneous.

          5.1 Except for the amendments set forth herein, all other terms and conditions of the License
shall remain in full force and effect.

          5.2 Capitalized terms used but not otherwise defined herein shall have the meanings assigned
to them in the License.

          5.3 This Amendment will be interpreted and construed in accordance with the laws of the State
of Missouri, excluding any choice of law rules that would direct the application of the laws of
another jurisdiction.

     IN WITNESS WHEREOF, the Parties have executed this Amendment as of the Effective Date.

	 	 	 	 	 	 	 
	THE CURATORS OF THE

UNIVERSITY OF MISSOURI	 	 	 	 
	 
	 	 	 	 	 	 
	By:

	 	/s/ Michael F. Nichols, Ph.D.
 

	 	 	 	 
	 
	 	 	 	 	 	 
	Name:

	 	Michael F. Nichols, Ph.D.	 	 	 	 
	 
	 	 	 	 	 	 
	Title:	 	Director, Office of Technology Management & Industry Relations
	 
	 	 	 	 	 	 
	SANTARUS, INC.	 	 	 	 
	 
	 	 	 	 	 	 
	By:

	 	/s/ Gerald T. Proehl	 	 	 	 
	 

	 	 	 	 	 	 
	 
	 	 	 	 	 	 
	Name:

	 	Gerald T. Proehl	 	 	 	 
	 
	 	 	 	 	 	 
	Title:

	 	President and CEO	 	 	 	 

 

			
	***	 	Certain information on this page has been omitted and filed separately with the Securities and
Exchange Commission. Confidential treatment has been requested with respect to the omitted
portions.

3

 

Exhibit A

PATENTS AND PATENT APPLICATIONS LICENSED

	 	 	 	 	 
	Patent App. No.	 	Filing Date	 	Title
	[***]

	 	[***]
	 	[***]
	[***]

	 	[***]
	 	[***]
	[***]

	 	[***]
	 	[***]
	[***]

	 	[***]
	 	[***]
	[***]

	 	[***]
	 	[***]
	[***]

	 	[***]
	 	[***]
	[***]

	 	[***]
	 	[***]
	[***]

	 	[***]
	 	[***]
	[***]

	 	[***]
	 	[***]
	[***]

	 	[***]
	 	[***]
	[***]

	 	[***]
	 	[***]
	[***]

	 	[***]
	 	[***]
	[***]

	 	[***]
	 	[***]
	[***]

	 	[***]
	 	[***]
	[***]

	 	[***]
	 	[***]
	[***]

	 	[***]
	 	[***]
	[***]

	 	[***]
	 	[***]
	[***]

	 	[***]
	 	[***]

 

			
	***	 	Certain information on this page has been omitted and filed separately with the Securities and
Exchange Commission. Confidential treatment has been requested with respect to the omitted
portions.

4

 

Exhibit B

[***]

 

			
	***	 	Certain information on this page has been omitted and filed separately with the Securities and
Exchange Commission. Confidential treatment has been requested with respect to the omitted
portions.

5

 

Exhibit C

	 	 	 	 	 
	Patent App. No.	 	Filing Date	 	Title
	[***]

	 	[***]
	 	[***]
	[***]

	 	[***]
	 	[***]
	[***]

	 	[***]
	 	[***]
	[***]

	 	[***]
	 	[***]
	[***]

	 	[***]
	 	[***]
	[***]

	 	[***]
	 	[***]
	[***]

	 	[***]
	 	[***]
	[***]

	 	[***]
	 	[***]
	[***]

	 	[***]
	 	[***]
	[***]

	 	[***]
	 	[***]
	[***]

	 	[***]
	 	[***]

 

			
	***	 	Certain information on this page has been omitted and filed separately with the Securities and
Exchange Commission. Confidential treatment has been requested with respect to
the omitted portions.

6Exhibit 10.2

 

Exhibit 10.2

CERTAIN MATERIAL (INDICATED BY AN ASTERISK) HAS BEEN OMITTED FROM THIS DOCUMENT PURSUANT TO A
REQUEST FOR CONFIDENTIAL TREATMENT. THE OMITTED MATERIAL HAS BEEN FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.

CO-PROMOTION AGREEMENT

     This Co-Promotion Agreement (this “Agreement”) is entered into this 24th day of August, 2007,
by and between C.B. Fleet Company, Incorporated, a Virginia corporation, and its subsidiary C.B.
Fleet Investment Corporation, a Delaware corporation (collectively “Fleet”) and Santarus, Inc., a
Delaware corporation (“Santarus”).

BACKGROUND

     A. Fleet currently markets and distributes its Fleet® Phospho-soda®
EZ-PrepTM Bowel Cleansing System product (the “Product”).

     B. Fleet and Santarus desire to enhance the marketing of the Product by enlisting the support
and participation of Santarus to promote and detail the Product.

AGREEMENT

     Now, therefore, in consideration of the foregoing and the mutual promises herein contained,
Fleet and Santarus hereby agree as follows:

	1.	 	Definitions.

     1.1 “Act” shall mean the United States Federal Food, Drug, and Cosmetic Act, as it may be
amended from time to time.

     1.2 “Affiliate” means a corporation or business entity that, directly or indirectly, is
controlled by, controls, or is under common control with any entity.  For this purpose, “control”
means the direct or indirect ownership of more than fifty percent (50%) of the voting or income
interest in such corporation or business entity, or such other relationship as, in fact,
constitutes actual control.

     1.3 “Bonus Period” means the period beginning [***] days after the Promotion Commencement Date
and ending [***] days after the end of the Term. In the event the parties elect to extend the
Term, the initial Bonus Period shall be twelve (12) months and successive Bonus Periods shall run
consecutively thereafter until [***] days after the end of the Term, as extended.

     1.4 “Call” means an in-person, face-to-face sales presentation of the Product made by a sales
representative with an applicable Medical Health Professional, which presentation is for the
purpose of promoting the sale of the Product and during which presentation the use, safety and
effectiveness of the Product are presented.

 

			
	***	 	Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

1

 

     1.5 “Current Good Manufacturing Practices” shall mean the current standards for manufacture,
as set forth in the Act and applicable regulations and guidelines promulgated thereunder or
successors thereto, as shall be in effect from time to time during the Term.

     1.6 “Effective Date” means the date first set forth above.

     1.7 “FDA” means the United States Food and Drug Administration.

     1.8 “Fleet Trademarks” means the trademark Fleet®, the Fleet Laboratories logo and
any other related trademark or service mark (whether registered or unregistered) containing the
word “Fleet.”

     1.9 “GAAP” means United States generally accepted accounting principles, as may be amended
from time to time.

     1.10 “Marketing Plan” means (i) the initial marketing plan developed by Fleet for the
promotion, marketing and sale of the Product in the Territory and provided to Santarus for review
prior to the Effective Date and (ii) additional plans developed by Fleet for such promotion,
marketing and sale of the Product in the Territory in reasonable detail and on at least a quarterly
basis throughout the Term. The Marketing Plan shall be reviewed by the Steering Committee, as
defined in Section 2.12, and Fleet shall reasonably consider input from Santarus provided through
the Steering Committee.

     1.11 “Medical Health Professional” means gastroenterologists and other associated health care
professionals, including nurses and affiliated office and clinic staff, who are involved in
recommending use of, educating patients concerning or developing protocols for use of the Product
(or similar products), and who are called on by the Santarus Sales Force during the Term.

     1.12 “Non-Serious Adverse Event” shall mean any adverse drug experience associated with the
use of the Product in humans, whether or not considered drug-related, which is not a Serious
Adverse Event.

     1.13 “Phospho-soda® Dose” shall mean two (2) 45 mL bottles of Phospho-soda®.

     1.14 “Product Technical Complaint” shall mean: (i) any complaint that questions the purity,
identity, potency or quality of the Product, its packaging or labeling or the compliance of the
Product with applicable laws, rules and regulations, including the Act and Current Good
Manufacturing Practices; (ii) any complaint that concerns any incident that causes the Product or
its labeling to be mistaken for, or applied to, another article; (iii) any bacteriological
contamination or significant chemical, physical or other change or deterioration in the Product;
(iv) any failure of the Product to meet the specifications therefor as required by applicable
regulatory authorities; or (v) any complaint or evidence of tampering with the Product.

     1.15 “Product Trademarks” mean (i) the trademark Phospho-soda® (US registration no.
0315096) associated with the Product, and any other related trademark or service mark containing
the word “Phospho-soda” or a close variant or derivative thereof; (ii) the trademark Phospho-soda
EZ-PrepTM (US application no. 78/830826) associated with the Product, and any other
related trademark or service mark containing the word “EZ-Prep” or a close variant or

2

 

derivative thereof; and (iii) any other trademark or service mark (whether registered or
unregistered) used on or with the Product or in any sales and marketing materials (other than Fleet
Trademarks or the Santarus Trademarks, as applicable) in the Territory during the Term.

     1.16 “Promotion Commencement Date” means the first date upon which the Product is promoted
within the Territory by the Santarus Sales Force to Medical Health Professionals.

     1.17 “Proprietary Information” means any and all scientific, clinical, regulatory, marketing,
financial and commercial information or data, whether communicated in writing, orally or by any
other means, which is owned or under the protection of one party and is provided by that party to
the other party in connection with this Agreement. Proprietary Information shall also include the
terms and conditions of this Agreement, as well as the progress of each party’s respective
activities and results under this Agreement.

     1.18 “Samples” means free samples of the Product supplied by Fleet to Santarus and provided by
the Santarus Sales Force to Medical Health Professionals.

     1.19 “Santarus Sales Force” means the sales representatives employed by or on behalf of
Santarus, as the case may be, for the detailing of the Product in the Territory to Medical Health
Professionals.  Santarus’ Sales Force may include, without limitation, any sales representatives
engaged through an arrangement with a contract sales organization. Santarus may utilize all or
part of the Santarus Sales Force in connection with its detailing activities under this Agreement.

     1.20 “Santarus Trademarks” means the trademark Santarus®, the Santarus corporate
logo and any other related trademark or service mark (whether registered or unregistered)
containing the word “Santarus.”

     1.21 “Serious Adverse Event” shall mean any adverse drug experience occurring at any dose that
results in any of the following outcomes: death, a life-threatening adverse drug experience,
inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant
disability/incapacity, or a congenital anomaly/birth defect. Important medical events that may not
result in death, be life-threatening, or require hospitalization may be considered a Serious
Adverse Event when, based upon appropriate medical judgment, they may jeopardize the patient or
subject and may require medical or surgical intervention to prevent one of the outcomes listed in
this definition. Examples of such medical events include allergic bronchospasm requiring intensive
treatment in an emergency room or at home, blood dyscrasias or convulsions that do not result in
inpatient hospitalization, or the development of drug dependency or drug abuse associated with the
use of the Product in humans, whether or not considered drug-related.

     1.22 “Term” shall have the meaning given in Section 10.1 of this Agreement.

     1.23 “Territory” means the United States of America.

     1.24 “Unit” means one retail carton of the Product, which consists of one 45 mL bottle of
Phospho-soda®, one 30 mL bottle of Phospho-soda®, one 12 fl. oz. mixing cup and two lemonade flavor
packets.

3

 

	2.	 	 Grants and Obligations.

     2.1 Grant of Co-Promotion Right.  Fleet hereby grants to Santarus, during the Term of
this Agreement, the non-exclusive right to promote and detail the Product in the Territory for its
labeled indications by conducting Calls through the Santarus Sales Force to Medical Health
Professionals, subject to the terms and conditions of this Agreement.

     2.2 Promotion Commencement Date. The parties anticipate that the Promotion
Commencement Date will occur as soon as reasonably practicable following the Effective Date, but
not later than November 1, 2007.

     2.3 Santarus Detailing Obligations. During the Term, Santarus shall be obligated to
perform a minimum of [***] Calls to Medical Health Professionals (the “Minimum Detailing
Obligation”) and shall be entitled to perform up to a maximum of [***] Calls (the “Maximum Number
of Details”); provided that such Minimum Detailing Obligation shall be subject to availability of
Samples and promotional and marketing materials to support Santarus’ detailing activities; and
provided further that the Maximum Number of Details may be increased upon mutual written agreement
of the parties.

     2.4 Fleet Marketing and Supply Obligations. In addition to any other obligations set
forth in this Agreement, during the Term, Fleet shall be obligated to use active, sustained
diligent efforts to: (i) maintain the authorization and/or ability to market the Product in the
Territory; and (ii) market and sell the Product in the Territory at a level of effort substantially
in accordance with the efforts described in Exhibit A hereto.

     2.5 Training and Promotional Materials.  Fleet shall create, develop, print and ship,
at its sole cost and expense, all training, sales and promotional materials relating to the Product
(including, without limitation, training manuals, sales detail aids, leave behind pieces and
Samples).  Santarus shall utilize the training, sales and promotional materials developed by Fleet
and will not, without Fleet’s prior review and approval, publish or distribute any sales or
promotional material with respect to the Product developed or created by or on behalf of Santarus. 
Fleet shall provide Santarus with copies of all training, sales and promotional materials relating
to the Product created or developed by Fleet during the Term at Fleet’s sole cost and expense
(including printing fees and shipping costs to members of the Santarus Sales Force and/or Santarus’
distribution facility, as designated by Santarus). Fleet shall be responsible for ensuring that
all training, sales and promotional materials are in compliance with applicable laws, rules and
regulations related thereto. Fleet shall provide copies of all proposed training, sales and
promotional materials to Santarus in a timely manner to allow for review and comment by Santarus’
internal copy approval committee prior to shipment for use by the Santarus Sales Force. Fleet
shall reasonably consider any comments provided by Santarus’ internal copy approval committee, and
Santarus reserves the right to not utilize any materials which are not ultimately approved for use
by its copy approval committee.

     2.6 Training Programs. Prior to the Promotion Commencement Date, Santarus and Fleet
shall conduct training for the Santarus Sales Force members who will be detailing the Product,
which training shall consist of [***] training modules and training by Fleet of Santarus sales
force trainers. Fleet shall make its training personnel available for consultation with Santarus
(including “train the trainer” type presentations).

 

			
	***	 	Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

4

 

     2.7 Santarus Detail Reports.  Following the Promotion Commencement Date, within [***]
days following the end of each calendar month during the Term, Santarus shall provide Fleet with a
written report summarizing Santarus’ detailing efforts pursuant to this Agreement for such prior
calendar month, including: the number of Calls made, the Medical Health Professionals who received
Calls and dates of Calls. Santarus’ monthly reports pursuant to this Section 2.7 shall be
transmitted to Fleet by email (to [***]) or to such other email addresses as Fleet may from time to
time designate in writing. 

     2.8 Compliance with Laws.  Fleet’s and Santarus’ activities with respect to the
Product shall be conducted (i) in a manner which is consistent with FDA and all other applicable
regulatory requirements which are then in effect with respect to the Product and with the PhRMA
Code on Interactions with Healthcare Professionals and applicable AMA guidelines; and (ii) in
compliance with all applicable laws, restrictions and regulations of the FDA, the Department of
Commerce, the Department of Health and Human Services and any other United States, state, local, or
applicable agency or authority.  Each of Fleet and Santarus shall limit its claims of efficacy and
safety for the Product to those that are consistent with approved promotional materials and shall
not add, delete or modify claims of efficacy and safety in the marketing of the Product under this
Agreement from those claims of efficacy and safety that are consistent with the applicable laws,
rules and regulations. 

     2.9 Samples.  During the Term, Fleet will provide Santarus with Samples of Product for
distribution by the Santarus Sales Force to Medical Health Professionals in connection with
Santarus’ promotion of the Product hereunder at Fleet’s sole cost and expense. Fleet shall ship
Samples, in the amounts reasonably requested from time to time by Santarus, to members of the
Santarus Sales Force and/or Santarus’ distribution facility; provided that Fleet will not be
obligated to provide Samples in excess of [***] Samples.

     2.10 Trademarks. 

          (i) Fleet hereby grants to Santarus a non-exclusive, royalty-free license to use the Product
Trademarks and Fleet Trademarks to promote the Product in accordance with the terms of this
Agreement. For purposes of this provision, “Fleet” includes C.B. Fleet Investment Corporation, a
Delaware corporation which owns the Phospho-soda® trademark.

          (ii) Each party acknowledges the validity of Santarus’ right, title and interest in and to the
Santarus Trademarks and the validity of Fleet’s right, title and interest in and to the Fleet
Trademarks and the Product Trademarks. The parties shall not have, assert or acquire any right,
title or interest in or to any of Santarus Trademarks (in the case of Fleet), or the Fleet
Trademarks or the Product Trademarks (in the case of Santarus) or the goodwill pertaining thereto,
except as otherwise explicitly provided in this Agreement.

     2.11 Non-Solicitation of Employees. The parties hereby agree that, throughout the
Term and for a period of [***] immediately thereafter, neither party will, directly or indirectly,
solicit for employment any employee of the other party (or of the other party’s designee);
provided, however, that the hiring of employees who respond to general advertisements for
employment (not targeted to employees of the other party or their designee) shall not be deemed to
violate the foregoing provision.

 

			
	***	 	Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

5

 

     2.12 Steering Committee. Promptly following the Effective Date, Fleet and Santarus
shall form a steering committee (the “Steering Committee”), comprised of [***] individuals, [***]
of whom shall be appointed by Fleet and [***] of whom shall be appointed by Santarus and all of
whom shall be qualified to appropriately represent such party at the Steering Committee level.
Each party may replace its representatives at any time, upon written notice to the other party.
The Steering Committee shall be chaired by one of the [***] Fleet representatives. The Steering
Committee will be used as the forum for each party to coordinate, provide strategic, operational
and performance input and work with the other party on the marketing and promotion strategy for
Product in the Territory. The Steering Committee will meet periodically as reasonably deemed
necessary by the Parties, to review and discuss: (i) the Marketing Plan (and any material changes
to such plan from time to time); (ii) the actual results as compared to the Marketing Plan; and
(iii) updates regarding any product development, clinical, regulatory, manufacturing/supply,
quality and commercial matters relating to the Product. The Steering Committee may perform such
other functions as may be mutually agreed by Fleet and Santarus. The first meeting of the
Steering Committee shall be held as soon as practicable after the Effective Date. Meetings of the
Steering Committee [***] take place face-to-face, but upon the agreement of both parties, can be
via other methods of communication, such as teleconferences or videoconferences. Notwithstanding
the creation and role of the Steering Committee, each party shall retain the rights, powers and
discretions granted to it hereunder. The Steering Committee shall not be delegated or vested with
any such rights, powers or discretions unless expressly provided for herein. Without limiting the
generality of the foregoing, the Steering Committee may not amend or modify this Agreement, which
may be amended or modified only as provided in Section 13.3.

     2.13 [***].

     2.14 Notices. In addition to any other specific notice requirements set forth herein,
Fleet shall provide Santarus with prompt written notice of any material developments or changes
relating to the Product, which could reasonably be expected to have any effect on Santarus’ rights
and obligations under this Agreement. Notwithstanding the generality of the foregoing, Fleet shall
provide prompt written notice of any of the following matters:

          (i) any material manufacturing matters relating to the Product (including potential shortages,
quality matters, significant Product Technical Complaints, voluntary or mandatory withdrawals or
recalls, etc.);

          (ii) any new litigation or material change to existing litigation relating to the Product or
to other related Fleet products, it being understood Fleet will notify Santarus of any product
liability suits filed with regard to the Product or any related product on a calendar monthly
basis, each report to be submitted no later than the [***] day of the following month; and

          (iii) any material communications with regulatory authorities relating to the Product.

 

			
	***	 	Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

6

 

3. Compensation.

     3.1 Co-Promotion Fee. During each calendar month of the Term in which Santarus
conducts detailing and promotional activities pursuant to this Agreement, Fleet shall pay Santarus
a Co-Promotion Fee equal to $[***] per Call made by the Santarus Sales Force to Medical Health
Professionals (the “Co-Promotion Fee”) in accordance with Section 3.3 hereinafter.

     3.2 Bonus Payments. In addition to the monthly Co-Promotion Fee, Santarus will be
entitled to receive a bonus payment (the “Bonus Payments”) calculated in accordance with the
formula below. The Bonus Payment shall be pro-rated in an equitable manner in the event that the
Agreement is terminated prior to the completion of a Bonus Period. The determination of the number
of [***] sold will be calculated by Fleet based on independent third party data purchased by Fleet,
including data from [***] as well as reported data for [***] and other retail outlets not captured
[***]. In the event the calculation below results in a negative number, the Bonus Payment shall be
zero as the parties do not intend the calculation to result in a payment by Santarus:

     [***] = Bonus Payment

	 	 	 	 	 
	 

	 	A =
	 	number of Units of Product sold during the Bonus Period in excess of [***]
Units. In the event the Term is extended, the parties will agree on the baseline
number of Units for future Bonus Periods.

     [***].

     3.3 Method of Payments. 

          (i) All payments to Santarus under this Agreement shall be made in U.S. Dollars.

          (ii) Fleet shall pay the Co-Promotion Fee to Santarus within [***] days after receipt of the
detailing report required in Section 2.7 from Santarus. Payment of the Co-Promotion Fee shall be
made by wire transfer to an account designated by Santarus.

          (iii) For the purposes of the Bonus Payment, Fleet shall provide a report to Santarus in
reasonable detail of Units sold [***] days following the end of the Bonus Period. The Bonus
Payment, if any, shall be paid by Fleet to Santarus within [***] following the end of the Bonus
Period. Payment of the Bonus Payments shall be made by wire transfer to an account designated by
Santarus.

     3.4 Late Payments; Interest. All payments under this Agreement shall bear interest
from the date due until paid at a rate equal to the prime rate effective for the date that payment
was due, plus [***] percent ([***]%), as quoted by the Wall Street Journal, New York Edition, on
the date such payment was due, or, if less, the maximum rate permitted by applicable law.

4. Regulatory Affairs.

 

			
	***	 	Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

7

 

     4.1 Regulatory Affairs.  Fleet shall be responsible, at its sole cost and expense, for
all regulatory responsibility relating to the ability to market and sell the Product in the
Territory in compliance with the Act.

     4.2 Communications with Regulatory Authorities.  Fleet shall be responsible, at its
sole cost and expense, for handling all communications with any government agencies regarding the
marketing of the Product in the Territory in accordance with all the other applicable laws, rules
and regulations.  Santarus shall notify Fleet within [***] days via facsimile of any inquiry or
other communication that it receives from the FDA concerning the Product.  Fleet shall handle all
communications with the FDA concerning the Product, including but not limited to post-marketing
reports of adverse drug experiences, and responding to any inquiries concerning post-marketing
reports and advertising or promotional materials, and shall provide copies of all such
communication to Santarus within [***] days via facsimile.  Notwithstanding the foregoing,
Santarus shall be able to communicate with any such governmental agency regarding the Product, to
the extent that such communication is necessary to comply with the terms of this Agreement or the
requirements of any applicable laws, rules or regulations.

     4.3 Notice of Adverse Events. Each party shall promptly notify the other party of any
event(s) that materially affect(s) or could materially affect the marketing of the Product,
including without limitation all Serious Adverse Events, Non-Serious Adverse Events, and
governmental inquiries. As between the parties, Fleet shall have the sole responsibility for
reporting and responding to such events to applicable governmental or regulatory authorities;
provided that Santarus may take such actions (including issuing such reports) as it determines are
required by applicable law.

     4.4 Medical Inquiries.  For all medical inquiries, including those related to
information outside of labeling or which Santarus and its sales representatives are unable or not
authorized under acceptable promotional guidelines to answer, Santarus and its representatives
shall direct such inquiries to Fleet’s Medical Affairs Department. As between the parties, any
responses to such inquiries from patients, medical practitioners, or other third parties shall be
provided solely by Fleet.

     4.5 Transition Responsibilities. The parties shall meet to develop a
pharmacovigilance plan to be agreed upon by the parties pursuant to which the parties shall
coordinate the fulfillment of their responsibilities pursuant to this Article 4 and other related
matters, and such plan shall be completed and effective no later than [***] days following the
Effective Date.

     4.6 Product Technical Complaints and Recalls.

          (i) If Santarus becomes aware of any Product Technical Complaint, Santarus shall notify Fleet
of such Product Technical Complaint within [***] days.

          (ii) As between the parties, Fleet shall have the sole authority and responsibility to respond
to any governmental or regulatory authorities, including without limitation the FDA, in connection
with Product Technical Complaints and medical complaints, and to handle all returns, recalls or
market withdrawals of the Product in accordance with applicable law, at Fleet’s sole cost and
expense.

 

			
	***	 	Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

8

 

          (iii) Each party shall promptly (but in any case, not later than [***]) notify the other party
in writing via facsimile of any order, request or directive of a court or other governmental or
regulatory authority to recall or withdraw the Product.

     4.7 Government Inspections and Inquiries. Upon being contacted by the FDA or any
other governmental or regulatory authority for any regulatory purpose pertaining specifically to
this Agreement or to the Product, Santarus shall notify Fleet within [***] days. Santarus agrees
that it shall not respond to any such agency making an inquiry of it until and only as directed by
Fleet; provided, however, that the foregoing shall not be construed to prevent Santarus in any way
from complying with any governmental or regulatory authority or applicable laws, rules or
regulations. Santarus may permit unannounced regulatory inspections and respond to the extent
necessary to comply with its obligations under applicable laws, rules or regulations.

     4.8 Debarment, Etc. Neither Fleet nor Santarus nor any of Fleet’s or Santarus’
employees or agents who will be performing services under this Agreement or otherwise with respect
to the Product (i) is under investigation by the FDA for debarment action or is presently debarred
under the Act or pursuant to the Generic Drug Enforcement Act of 1992 (21 U.S.C. ‘301 et seq.) or
(ii) has violated, or is under investigation for violating, any state or federal health care
programs or any federal or state anti-kickback laws or regulations. Each of Fleet and Santarus
will notify the other party in writing within [***] days upon any inquiry or the commencement of
any of the foregoing proceedings concerning such party or any of its employees or agents performing
services under this Agreement.

5. Supply and Distribution. Fleet shall be responsible, at its sole cost and expense, for
Product manufacturing and distribution and Product inventory and receivables.  Fleet shall
manufacture or cause to be manufactured the Product and Samples in accordance with all applicable
laws, including without limitation the Act and all applicable rules and regulations thereunder, and
Current Good Manufacturing Practices. Fleet will supply and distribute the Product to customers in
accordance with the specifications and requirements of the FDA (and any other applicable regulatory
authorities) for sale of the Product in the Territory and all applicable laws, including without
limitation the Act and all applicable rules and regulations thereunder and Current Good
Manufacturing Practices.

6. Representations and Warranties.

     6.1 Representations and Warranties. Each party hereby represents and warrants to the
other party as follows:

     (i) It is a corporation duly organized, validly existing and in good standing under the laws
of the jurisdiction of its incorporation.  It has all requisite power and authority to carry on its
business and to own and operate its properties and assets.  The execution, delivery and performance
of this Agreement have been duly authorized by its Board of Directors.  Such party has obtained all
authorizations, consents and approvals, governmental or otherwise, necessary for the execution and
delivery of this Agreement, and to otherwise perform such party’s obligations under this Agreement.

     (ii) Except as described on Exhibit B attached hereto (in the case of Fleet) (the
“Fleet Pending Litigation”), there is no pending or, to its knowledge, threatened litigation

 

			
	***	 	Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

9

 

involving it which could reasonably be expected to have any material adverse effect on this
Agreement or on its ability to perform its obligations hereunder.

          (iii) There is no indenture, contract, or agreement to which it is a party or by which it is
bound which prohibits, conflicts with or would prohibit the execution and delivery by it of this
Agreement or the performance or observance by it of any material term or condition of this
Agreement.

     6.2 Additional Fleet Representations and Warranties. Fleet further hereby represents
and warrants to Santarus that (i) the data regarding the efficacy and safety of the Product that is
contained in regulatory filings submitted to the FDA requesting that FDA find the Product and
related products to be generally recognized as safe and effective is complete and accurate in all
materials respects, did not at the time of filing contain any misstatement of a material fact
related to safety or efficacy nor omit to state any material fact in Fleet’s possession related to
safety or efficacy; (ii) as of the Effective Date, [***] Fleet has received no notice of a third
party claiming any ownership interest in the intellectual property (including patent and trademark
rights) covering the Product or its uses; (iii) Fleet has the exclusive right to promote, market
and sell the Product in the Territory and to perform its obligations under this Agreement; (iv) as
of the Effective Date, Fleet is unaware of any third-party infringement of the Product intellectual
property (including patent and trademark rights) which would have a material adverse effect on the
rights granted to Santarus hereunder; (v) the Product’s label and labeling and the related written
sales, advertising, marketing, promotional and training materials provided to Santarus by Fleet
comply with all applicable laws, rules and regulations; (vi) prior to the Effective Date, Fleet has
disclosed to Santarus all material information in its possession relating to the Product or
Santarus’ activities under this Agreement; and (vii) Fleet’s insurance coverage and reserves are
sufficient to cover its obligations arising out of all pending and expected litigation involving it
and its indemnification obligations in this Agreement.

7. Indemnification and Insurance.

     7.1 Indemnification. 

          (i) Each party will defend, at its own expense, indemnify and hold harmless the other party
and its directors, officers, employees, agents and Affiliates from and against any and all damages,
liabilities, losses, costs, and expenses, including reasonable attorneys fees, arising out of any
claim, suit or proceeding asserted against the other party (each, a “Claim” and collectively,
“Claims”) to the extent such Claim arises out of or relates to (A) any material breach or violation
of, or failure to perform, any covenant or agreement made by such indemnifying party in this
Agreement, unless waived in writing by the indemnified party; (B) any material breach of the
representations or warranties made by such indemnifying party in this Agreement; or (C) the
negligence or willful misconduct of the indemnifying party, except (under any of (A) and (B)) to
the extent arising out of the breach, violation, failure, negligence or willful misconduct of the
indemnified party. 

          (ii) In addition and notwithstanding (i) above, Fleet will defend, at its own expense,
indemnify and hold harmless Santarus and its directors, officers, employees, agents and Affiliates
from and against any and all Claims to the extent such Claim arises out of or relates to: (A) any
personal injury (including death) and/or property damage resulting from the handling,

 

			
	***	 	Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

10

 

possession, sale or use of the Product or any other Fleet products; and (B) any other
liability arising out of the manufacture, marketing, labeling, distribution, sale or use of the
Product (or any other Fleet products), including claims of infringement of third party intellectual
property rights and product liability claims and including claims related to Santarus’ activities
hereunder, except (under any of (A) and (B)) to the extent arising out of the negligence or willful
misconduct of Santarus.

          (iii) Each party agrees that it shall promptly notify the other in writing of any Claim and
give the indemnifying party full information and full cooperation and assistance in connection
therewith at the indemnifying party’s expense.  The indemnifying party shall have the sole right to
control the defense of any Claim or action and the sole right to settle or compromise any such
Claim, except that the prior written consent of the indemnified party shall be required in
connection with any settlement or compromise which could (A) place any obligation on or require any
action of such indemnified party; (B) admit or imply any liability or wrongdoing of such
indemnified party; or (C) adversely affect the goodwill or public image of such indemnified party. 
Notwithstanding the foregoing, the indemnified party may participate therein through counsel of its
choice, but the cost of such counsel shall be borne solely by the indemnified party.

     7.2 Insurance. During the Term of this Agreement, each party shall maintain a policy
or policies of commercial general liability insurance in an amount of no less than [***] Dollars
($[***]) annual aggregate and per occurrence and product liability insurance in an amount of no
less than [***] Dollars ($[***]) annual aggregate and per occurrence, with a deductible or
self-insurance retention with regards to product liability insurance of no greater than [***]
($[***]) annual aggregate, and in the case of Fleet shall name Santarus as an insured under its
policy. Each party shall provide to the other within thirty (30) days of the Effective Date a
Certificate of Insurance. Each party shall promptly notify the other party of any cancellation,
termination, modification or other change in its insurance coverage.

     7.3 Survival.  The provisions of this Article 7 shall survive termination of this
Agreement and shall remain in effect until a date [***] years after the Term of this Agreement.

8. Confidentiality.

     8.1 Confidentiality Obligation.  Except as specifically authorized by this Agreement,
each party shall, for the Term and for [***] years after the expiration or termination of this
Agreement, keep confidential, not disclose to third parties (other than consultants bound in
writing, financial advisors and outside counsel who agree to protect the Proprietary Information no
less stringently than herein) and use only for the purposes authorized herein all Proprietary
Information provided by the other under this Agreement; provided, however, that the foregoing
obligations of confidentiality shall not apply to the extent that any such information is (i)
already known to the recipient at the time of disclosure as evidenced by its prior written records;
(ii) published or publicly known prior to or after disclosure other than through unauthorized acts
or omissions of the recipient; (iii) disclosed in good faith to the recipient by a third party
entitled to make such disclosure; or (iv) independently developed by or on behalf of the recipient
without recourse to the disclosure herein as documented in writing.  Notwithstanding the aforesaid,
the recipient may disclose Proprietary Information to governmental agencies as required by law,
provided that the other party is provided with prior written notice and a reasonable opportunity to
obtain confidential treatment or other protective order.

 

			
	***	 	Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

11

 

     8.2 Survival.  The provisions of this Article 8 shall survive termination of this
Agreement and shall remain in effect until a date [***] after the Term of this Agreement.

9. Maintenance of Books and Records; Audits.

     9.1 Maintenance of Books and Records. Each party shall maintain complete and accurate
books and records in sufficient detail, in accordance with GAAP and all applicable laws, rules,
ordinances and regulations, to enable verification of the performance of such party’s obligations
under this Agreement. Such records shall be maintained for a period of [***] years after the end
of the Term or longer if required by applicable law. 

     9.2 Payment Audits.  Santarus may request one or more audits of the relevant books and
records of Fleet in order to verify the calculation of any payments to be made hereunder. Such
records shall be made available by Fleet for audit by an independent certified public accounting
firm designated by Santarus and reasonably acceptable to Fleet.  The auditor will only examine such
books and records during business hours but not more than [***] each fiscal year while this
Agreement remains in effect and for [***] years thereafter.  The fees and expenses of the auditor
performing such verification shall be borne by Santarus; provided, however, that if any
verification reveals that Fleet has reported incorrectly, and the amount of such discrepancy is at
least [***] percent ([***]%) of the aggregate amount that should have been reported for the period
examined, then Fleet shall pay the entire amount of the fees and expenses for such verification.

10. Term and Termination.

     10.1 Term.  The term of this Agreement (the “Term”) shall commence on the Effective
Date and shall continue, unless terminated sooner in accordance with the terms hereof, until the
first anniversary of the Promotion Commencement Date; provided that the parties may extend the Term
of the Agreement upon mutual written agreement.

     10.2 Termination by Fleet.

          (i) Fleet shall have the right to terminate this Agreement at any time upon written notice to
Santarus if Santarus materially breaches any of its representations, warranties, covenants or
agreements set forth in this Agreement or otherwise materially defaults in the performance of any
of its duties or obligations under this Agreement, which breach or default is not cured within
sixty (60) days after written notice is given to Santarus specifying the breach or default.

          (ii) Fleet shall have the right to terminate this Agreement immediately upon written notice to
Santarus if Santarus shall become insolvent, file or consent to the filing of a petition under any
bankruptcy or insolvency law or have any such petition filed against it which has not been stayed
within thirty (30) days of such filing or have a receiver appointed over any of Santarus’ property
or assets.

          (iii) Fleet shall have the right to terminate this Agreement immediately upon written notice
to Santarus in the event of a recall or withdrawal of the Product from the Territory resulting from
a significant safety risk inherent in the Product and not due to tampering, a

 

			
	***	 	Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

12

 

remediable manufacturing problem, or other defect that can be cured with respect to Products
manufactured after such risk is discovered.

          (iv) Fleet shall have the right to terminate this Agreement immediately upon written notice to
Santarus in the event that any governmental or regulatory authority takes any action or raises any
objection that prevents Fleet from performing its obligations hereunder or otherwise makes such
activity unlawful.

          (v) Fleet
shall have the right to terminate this Agreement at any time by
providing One Hundred and Twenty (120) days
advance written notice to Santarus.

     10.3 Termination by Santarus.

          (i) Santarus shall have the right to terminate this Agreement at any time upon written notice
to Fleet if Fleet materially breaches any of its representations, warranties, covenants or
agreements set forth in this Agreement or otherwise materially defaults in the performance of any
of its duties or obligations under this Agreement, which breach or default is not cured within
sixty (60) days after written notice is given to Fleet specifying the breach or default.

          (ii) Santarus shall have the right to terminate this Agreement immediately upon written notice
to Fleet if Fleet shall become insolvent, file or consent to the filing of a petition under any
bankruptcy or insolvency law or have any such petition filed against it which has not been stayed
within thirty (30) days of such filing or have a receiver appointed over any of Fleet’s property or
assets.

          (iii) Santarus shall have the right to terminate this Agreement immediately upon written
notice to Fleet in the event of a recall or withdrawal of the Product from the Territory resulting
from a significant safety risk inherent in the Product and not due to tampering, a remediable
manufacturing problem, or other defect that can be cured with respect to Products manufactured
after such risk is discovered.

          (iv) Santarus shall have the right to terminate this Agreement immediately upon written notice
to Fleet in the event that any governmental or regulatory authority takes any action or raises any
objection that prevents Santarus from performing its obligations hereunder or otherwise makes such
activity unlawful.

          (v) Santarus shall have the right to terminate this Agreement at any time by providing One Hundred and Twenty (120) days advance written notice to Fleet.

     10.4 Post-Termination Obligations.  No additional payment obligations arising under
Article 3 hereof shall accrue after the date of expiration or termination of this Agreement;
provided, however, that expiration or termination of this Agreement shall not relieve either party
of any obligations accruing prior to such expiration or termination.  Certain provisions of this
Agreement by their terms continue after the expiration or termination of this Agreement, including
without limitation Sections 2.11, 2.13, 3.2, 3.3, 3.4, 4.2, 4.7, 7, 8, 9, 10.4, 11, 12 and 13.  In
addition, any other provisions required to interpret and enforce the parties’ rights and
obligations under this Agreement shall also survive, but only to the extent required for the full
observation and performance of this Agreement.  Upon the expiration or termination of this
Agreement pursuant to this Article 10, each party shall promptly transfer and return to the other

13

 

party or destroy all Proprietary Information of the other party (provided that each party may
keep one copy of such Proprietary Information for archival purposes only).

11. Publicity. Neither party will originate any publicity, news release, public comment or
other public announcement, written or oral, whether to the press, to stockholders, or otherwise,
relating to this Agreement, without the consent of the other party, except for such announcements
which, in accordance with the advice of legal counsel to the party making such announcement, are
required by law or for such announcements that contain the same disclosure as in prior
permitted/approved public announcements.  Except as otherwise permitted pursuant to the immediately
preceding sentence, any party making any announcement which is required by law will, unless
prohibited by law, give the other party an opportunity to review the form and content of such
announcement and comment before it is made.  Either party shall have the right to make such filings
with governmental agencies, including without limitation the United States Securities and Exchange
Commission, as to the contents and existence of this Agreement as it shall reasonably deem
necessary or appropriate (provided that the parties will reasonably cooperate with respect to
obtaining confidential treatment of sensitive information, as appropriate). The parties have
agreed upon the form and contents of a press release to be issued by Santarus promptly following
execution of this Agreement. The provisions of this Article 11 shall survive termination of this
Agreement and shall remain in effect until a date [***] years after the Term of this Agreement.

12. Notices.

     12.1 Notices.  Unless otherwise provided herein, all notifications, demands, approvals
and communications required to be made under this Agreement shall be given in writing and shall be
effective when either personally delivered or sent by overnight courier or sent by facsimile if
followed by overnight courier addressed as set forth below.  The parties hereto shall have the
right to notify each other of changes of address during the Term of this Agreement.

     If to Santarus, to:

SANTARUS, INC.

10590 W. Ocean Air Drive, Suite 200

San Diego, CA 92130

Attention: President and CEO

Facsimile: (858) 314-5701

     With a copy to:

SANTARUS, INC.

10590 W. Ocean Air Drive, Suite 200

San Diego, CA 92130

Attention: Legal Affairs Department

Facsimile: (858) 314-5702

 

			
	***	 	Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

14

 

     If to Fleet, to:

	 	 	 	 	 
	 
	 	C.B. FLEET COMPANY, INC.	 	C.B. FLEET INVESTMENT CORPORATION
	 
	 	4615 Murray Place	 	103 Foulk Road, Suite 202
	 
	 	Lynchburg, VA  24506	 	Wilmington, DE  19803
	 
	 	Attention:  Steve Ruhf	 	Attention:  Pamela Jasinski
	 
	 	Facsimile:  (434) 528-0430	 	Facsimile:  (302) 652-8667

     With a copy to:

SHEPPARD MULLIN RICHTER & HAMPTON LLP

1300 I Street, NW

11TH Floor East

Washington, D.C. 20006

Attention: Peter S. Reichertz

Facsimile: (202) 312-9426

     12.2 Receipt. Any such notice mailed as aforesaid shall be deemed to have been
received by and given to the addressee on the date specified on the notice of receipt and delivery
evidenced to the sender.

13. Miscellaneous.

     13.1 Assignment.  This Agreement may be assigned by either party without the consent
of the other party to an Affiliate. In addition, Santarus may assign this Agreement to a third
party in connection with the acquisition of Santarus (whether by merger, asset sale or otherwise)
or the business of Santarus associated with the Product.  This Agreement may not otherwise be
assigned by either party without the prior written consent of the other party, which consent shall
not be unreasonably withheld or delayed. 

     13.2 Independent Contractors.  Nothing herein contained shall be construed to
constitute the parties hereto as partners or as joint venturers, or either as agent for the other. 
No employee or representative of a party shall have any authority to bind or obligate the other
party to this Agreement for any sum in any manner whatsoever, or to create or impose any
contractual or other liability on the other party without said party’s authorized written
approval.  For all purposes, and notwithstanding any other provision of this Agreement to the
contrary, Santarus’ legal relationship under this Agreement to Fleet shall be that of independent
contractor.

     13.3 Entire Agreement.  This Agreement represents the entire agreement between the
parties concerning the subject matter hereof and supersedes all prior or contemporaneous oral or
written agreements of the parties.  This Agreement may be modified, amended or changed only by a
written instrument signed and delivered by the parties, with clear intent to modify, amend or
change the provisions hereof.

     13.4 Limitation on Damages.  Neither Fleet nor Santarus (which for the purposes of
this Section 13.4 shall include their respective Affiliates, directors, officers, employees and
agents) shall have any liability to the other for any punitive damages, special, incidental,
consequential or indirect damages, relating to or arising from this Agreement, even if such damages
may have been foreseeable. For the avoidance of doubt, nothing in this Section 13.4

15

 

shall be interpreted to limit the indemnification obligation of either party in connection
with the characterization of damages or losses claimed by a third party as being punitive, special,
incidental, consequential or indirect or other like damages or losses.

     13.5 Force Majeure. Neither party shall be liable to the other party for any failure
to perform as required by this Agreement if the failure to perform is due to circumstances
reasonably beyond such party’s control including, without limitation, any act of God, civil
disorder or commotion, act of aggression, fire, explosion, flood, drought, war, sabotage, embargo,
utility failure, material shortage, labor disturbance, national health emergency, or appropriation
of property. A party whose performance is affected by a force majeure event shall take prompt
action using all commercially reasonable efforts to remedy the effects of the force majeure event.

     13.6 Counterparts.  This Agreement may be executed in several counterparts, each of
which shall be deemed to be an original.

     13.7 Governing Law.  This Agreement shall be construed and governed in all aspects
under and in accordance with the law of the State of New York (excluding its or any other
jurisdiction’s choice of law principles).

     13.8 Waiver.  Except to the extent that a party may have otherwise agreed in writing,
no waiver by such party of any breach by any other party of any of the other party’s obligations,
agreements or covenants hereunder shall be deemed to be a waiver by such first party of any
subsequent or other breach of the same or any other obligation, agreement or covenant; nor shall
any forbearance by a party to seek a remedy for any breach by the other be deemed a waiver by said
party of its rights or remedies with respect to such breach or of any subsequent or other breach of
the same or any other obligation, agreement or covenant.

     13.9 Binding Effect.  Except as provided in Section 13.1, this Agreement shall be
binding upon and inure to the benefit of the parties to this Agreement and their respective
successors.

     13.10 Headings.  Headings as used in this Agreement are for convenience only and are
not to be construed as having any substantive effect by way of limitation or otherwise.  References
to Articles or Sections herein are, unless otherwise indicated, references to the designated
Articles or Sections of this Agreement, unless the content requires otherwise.

     13.11 Severability.  If one or more of the provisions of this Agreement shall, by any
court or under any provision of law, be found to be void or unenforceable, the agreement as a whole
shall not be affected thereby, and the provisions in question shall be replaced by an
interpretation in conformity with law which comes closer to effecting the parties original
intention.

[Signature Page Follows]

16

 

     IN WITNESS WHEREOF, the parties have caused this Agreement to be executed and delivered by
their undersigned duly authorized representatives as of the Effective Date.

	 	 	 	 	 	 	 	 	 
	SANTARUS, INC.	 	C.B. FLEET COMPANY, INCORPORATED	 	 
	 
	 	 	 	 	 	 	 	 
	By: 

Name:

	 	     /s/ Gerald T. Proehl
 

Gerald T. Proehl
	 	By:

Name:
	 	     /s/ R. Bruce Montgomery, Jr.
 

R. Bruce Montgomery, Jr.
	 	 
	Title:

	 	President and CEO
	 	Title:
	 	 Vice President	 	 
	 
	 	 	 	 	 	 	 	 
	 	 	 	 	C.B. FLEET INVESTMENT CORPORATION	 	 
	 
	 	 	 	 	 	 	 	 
	 

	 	 	 	By:
	 	     /s/ Robert A. Lemon	 	 
	 

	 	 	 	 	 	 	 	 
	 

	 	 	 	Name:
	 	 Robert A. Lemon	 	 
	 

	 	 	 	Title:
	 	 President	 	 

17

 

EXHIBIT A

Fleet Marketing Obligations

	 	 	 	 	 
	[***]
	 	 	 	 
	 
	 	 	[***]	 
	[***]
	 	 	[***]	 
	[***]
	 	 	[***]	 
	[***]
	 	 	[***]	 
	[***]
	 	 	[***]	 
	[***]
	 	 	[***]	 
	[***]
	 	 	[***]	 
	[***]
	 	 	[***]	 
	[***]
	 	 	[***]	 
	[***]
	 	 	[***]	 
	[***]
	 	 	[***]	 
	[***]
	 	 	[***]	 
	 
	[***]
	 	 	 	 
	[***]
	 	 	[***]	 
	[***]
	 	 	[***]	 
	[***]
	 	 	[***]	 
	[***]
	 	 	[***]	 
	[***]
	 	 	[***]	 
	[***]
	 	 	[***]	 
	[***]
	 	 	[***]	 
	[***]
	 	 	[***]	 
	[***]
	 	 	[***]	 
	[***]
	 	 	[***]	 
	[***]
	 	 	[***]	 
	[***]
	 	 	[***]	 
	[***]
	 	 	[***]	 
	[***]
	 	 	[***]	 
	 
	[***]
	 	 	 	 

 

			
	***	 	Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

18

 

EXHIBIT B

C.B. Fleet Company, Inc.

Litigation Summary

	 	 	 	 	 
	CASE	 	CIVIL ACTION NO.	 	VENUE
	Sonntag v. C.B. Fleet

	 	2:07-CV-274
	 	United States District Court
	 

	 	 	 	District of Washington
	 

	 	 	 	WASHINGTON
	 
	 	 	 	 
	Pitman v. C.B. Fleet

	 	07cv 3686
	 	United States District Court
	 

	 	 	 	District of Minnesota
	 

	 	 	 	MINNESOTA
	 
	 	 	 	 
	Fisher v. C.B. Fleet

	 	001172/05
	 	Supreme Court
	 

	 	 	 	Nassau County
	 

	 	 	 	NEW YORK
	 
	 	 	 	 
	Ford v. C.B. Fleet

	 	4:07-CV-01079
	 	United States District Court
	 

	 	 	 	Southern District of Texas
	 

	 	 	 	TEXAS
	 
	 	 	 	 
	Levine v. C.B. Fleet

	 	05CV1366
	 	Supreme Court
	 

	 	 	 	County of Queens
	 

	 	 	 	NEW YORK
	 
	 	 	 	 
	Quillin v. C.B. Fleet

	 	23-C-07-000075OT
	 	Circuit Court
	 

	 	 	 	Worcester County
	 

	 	 	 	MARYLAND
	 
	 	 	 	 
	Kurtz v. C.B. Fleet

	 	104208/07
	 	Supreme Court
	 

	 	 	 	County of New York
	 

	 	 	 	NEW YORK
	 
	 	 	 	 
	Taylor v. C.B. Fleet

	 	107485/06
	 	Supreme Court
	 

	 	 	 	County of New York
	 

	 	 	 	NEW YORK
	 
	 	 	 	 
	Ace v. C.B. Fleet

	 	07-60751-CIV-MARRA
	 	United States District Court
	 

	 	 	 	Southern District of Florida
	 

	 	 	 	West Palm Beach Division
	 

	 	 	 	FLORIDA
	 
	 	 	 	 
	Matsui v. C.B. Fleet

	 	P/31357
	 	16th Judicial Court
	 

	 	 	 	Macomb County Circuit Court
	 

	 	 	 	MICHIGAN
	 
	 	 	 	 
	Garrett v. C.B. Fleet

	 	4:07-CV-00729-HGD
	 	United States District Court
	 

	 	 	 	Northern District of Alabama
	 

	 	 	 	ALABAMA
	 
	 	 	 	 
	Birmingham v. C.B. Fleet

	 	1107-CV-00534
	 	United States District Court
	 

	 	 	 	Southern District of Ohio
	 

	 	 	 	OHIO
	 
	 	 	 	 

19

 

	 	 	 	 	 
	CASE	 	CIVIL ACTION NO.	 	VENUE
	Cantu v. C.B. Fleet

	 	 2:06-CV-2168
	 	United States District Court
	 

	 	 	 	Western District OF Louisiana
	 

	 	 	 	Lake Charles Division
	 

	 	 	 	LOUISIANA
	 
	 	 	 	 
	Kowalczyk v. C.B. Fleet

	 	Not yet assigned.
	 	United States District Court
	 

	 	 	 	District of Massachusetts
	 

	 	 	 	MASSACHUSETTS
	 
	 	 	 	 
	Bell and Taylor v. C.B. Fleet

	 	2006CV125849
	 	Superior Court
	 

	 	 	 	Fulton County
	 

	 	 	 	GEORGIA
	 
	 	 	 	 
	DePaola v. C.B. Fleet

	 	MICV2007-00989-B
	 	Superior Court
	 

	 	 	 	Middlesex County
	 

	 	 	 	MASSACHUSETTS
	 
	 	 	 	 
	Williams v. C.B. Fleet

	 	1:07-CV-512-LG-5MR
	 	United States District Court
	 

	 	 	 	Southern District of Mississippi
	 

	 	 	 	MISSISSIPPI
	 
	 	 	 	 
	Bladen v. C.B. Fleet

	 	6:06-CV-0973
	 	United States District Court
	 

	 	 	 	Western District Louisiana
	 

	 	 	 	Lafayette Division
	 

	 	 	 	LOUISIANA
	 
	 	 	 	 
	Grant v. C.B. Fleet

	 	07cv3681RHK/AJB
	 	United States District Count
	 

	 	 	 	District of Minnesota
	 

	 	 	 	MINNESOTA
	 
	 	 	 	 
	George v. C.B. Fleet

	 	2007-1684-CZ
	 	Macomb County
	 

	 	 	 	Circuit Court
	 

	 	 	 	MICHIGAN
	 
	 	 	 	 
	Lannon v. C.B. Fleet

	 	07-2084-CZ
	 	Macomb County
	 

	 	 	 	Circuit Court
	 

	 	 	 	MICHIGAN
	 
	 	 	 	 
	Paris v. C.B. Fleet

	 	KC 07-506
	 	Kent County Superior Court
	 

	 	 	 	RHODE ISLAND
	 
	 	 	 	 
	Bracey v. C.B. Fleet

	 	06-3238
	 	United States District Court
	 

	 	 	 	Eastern District of Louisiana
	 

	 	 	 	LOUISIANA
	 
	 	 	 	 
	Krieger v. C.B. Fleet

	 	110380/05
	 	Supreme Court
	 

	 	 	 	County of New York
	 

	 	 	 	NEW YORK
	 
	 	 	 	 
	Paragallo v. C.B. Fleet

	 	108628/06
	 	Supreme Court
	 

	 	 	 	County of New York
	 

	 	 	 	NEW YORK
	 
	 	 	 	 
	Freedman v. C.B. Fleet

	 	07-3028
	 	Providence County Superior Court
	 

	 	 	 	RHODE ISLAND

20

 

	 	 	 	 	 
	CASE	 	CIVIL ACTION NO.	 	VENUE
	Mudd v. C.B. Fleet

	 	1:07-CV-01432-JL
	 	United States District Court
	 

	 	 	 	District of Colorado
	 

	 	 	 	COLORADO
	 
	 	 	 	 
	Preiss v. C.B. Fleet

	 	07-3688 DSO/JJG
	 	United States District Court
	 

	 	 	 	District of Minnesota
	 

	 	 	 	MINNESOTA
	 
	 	 	 	 
	Marks v. C.B. Fleet

	 	106980/06
	 	Supreme Court
	 

	 	 	 	County of New York
	 

	 	 	 	NEW YORK
	 
	 	 	 	 
	Weiss v. C.B. Fleet

	 	MON-L-895-06
	 	Superior Court
	 

	 	 	 	Monmouth County
	 

	 	 	 	NEW JERSEY
	 
	 	 	 	 
	Addeo v. C.B. Fleet

	 	106682/06
	 	Supreme Court
	 

	 	 	 	County of New York
	 

	 	 	 	NEW YORK
	 
	 	 	 	 
	Swanson v. C.B. Fleet

	 	2:07-cv-257-JCC
	 	United States District Court
	 

	 	 	 	Western District of Washington
	 

	 	 	 	WASHINGTON
	 
	 	 	 	 
	Heffernan v. C.B. Fleet

	 	 06-10230
	 	Supreme Court
	 

	 	 	 	Westchester County
	 

	 	 	 	NEW YORK
	 
	 	 	 	 
	Steinleitner v. C.B. Fleet

	 	07-3685 MJD/AJB
	 	United States District Court
	 

	 	 	 	District of Minnesota
	 

	 	 	 	MINNESOTA
	 
	 	 	 	 
	Sapan v. C.B. Fleet

	 	102154/07
	 	Supreme Court
	 

	 	 	 	County of New York
	 

	 	 	 	NEW YORK
	 
	 	 	 	 
	Woodward v. C.B. Fleet

	 	07-CV-01422-RPM
	 	United States District Court
	 

	 	 	 	District of Colorado
	 

	 	 	 	COLORADO
	 
	 	 	 	 
	Crowell v. C.B. Fleet

	 	07-3029
	 	Providence County Superior Court
	 

	 	 	 	RHODE ISLAND
	 
	 	 	 	 
	Requa v. C.B. Fleet

	 	06-cv-01981-PSF-MEH
	 	United States District Court
	 

	 	 	 	District of Colorado
	 

	 	 	 	COLORADO
	 
	 	 	 	 
	DiBello v. C.B. Fleet

	 	CV-05-5000276-s
	 	Superior Court
	 

	 	 	 	Judicial District of Danbury
	 

	 	 	 	CONNECTICUT
	 
	 	 	 	 
	Wilkat v. C.B. Fleet

	 	108740/07
	 	Supreme Court
	 

	 	 	 	County of New York
	 

	 	 	 	NEW YORK

21

 

	 	 	 	 	 
	CASE	 	CIVIL ACTION NO.	 	VENUE
	Anderson v. C.B. Fleet

	 	07cv3682ADM/JSM
	 	United States District Court
	 

	 	 	 	District of Minnesota
	 

	 	 	 	MINNESOTA
	 
	 	 	 	 
	Sevcik v. C.B. Fleet

	 	07-3689 JMR/FLN
	 	United States District Court
	 

	 	 	 	District of Minnesota
	 

	 	 	 	MINNESOTA
	 
	 	 	 	 
	Stambaugh v. C.B. Fleet

	 	 07cv3684 JMR/FLN
	 	United States District Court
	 

	 	 	 	District of Minnesota
	 

	 	 	 	MINNESOTA
	 
	 	 	 	 
	Hays v. C.B. Fleet

	 	105CV048258
	 	County of Santa Clara
	 

	 	 	 	CALIFORNIA
	 
	 	 	 	 
	Goza v. C.B. Fleet

	 	680CL07001469-00
	 	City of Lynchburg Circuit Court
	 

	 	 	 	VIRGINIA
	 
	 	 	 	 
	Nelson v. C.B. Fleet

	 	07-3683 PAM/JSM
	 	United States District Court
	 

	 	 	 	District of Minnesota
	 

	 	 	 	MINNESOTA
	 
	 	 	 	 
	Curran v. C.B. Fleet

	 	GC0339194
	 	County of Los Angeles
	 

	 	 	 	Northeast District
	 

	 	 	 	CALIFORNIA
	 
	 	 	 	 
	Thomas v. C.B. Fleet

	 	5:07-182-JMH
	 	United States District Court
	 

	 	 	 	Eastern District of Kentucky
	 

	 	 	 	Central Division of Lexington
	 

	 	 	 	KENTUCKY
	 
	 	 	 	 
	Sotiriou v. C.B. Fleet

	 	06118325
	 	Supreme Court
	 

	 	 	 	County of New York
	 

	 	 	 	NEW YORK
	 
	 	 	 	 
	Weisser v. C.B. Fleet

	 	Not yet assigned.
	 	Morgan County
	 

	 	 	 	COLORADO
	 
	 	 	 	 
	Fakler v. C.B. Fleet

	 	106979/06
	 	Supreme Court
	 

	 	 	 	County of New York
	 

	 	 	 	NEW YORK
	 
	 	 	 	 
	Rogers v. C.B. Fleet

	 	4:06-CV-03586
	 	United States District Court
	 

	 	 	 	Southern District of Texas
	 

	 	 	 	TEXAS
	 
	 	 	 	 
	Hurlburt v. C.B. Fleet

	 	06-cv-6225 (NRB)(UA)
	 	United States District Court
	 

	 	 	 	Southern District of New York
	 

	 	 	 	NEW YORK
	 
	 	 	 	 
	LeSage v. C.B. Fleet

	 	5:07-cv-00166-SMH-MLH
	 	United States District Court
	 

	 	 	 	Western District of Louisiana
	 

	 	 	 	LOUISIANA
	 
	 	 	 	 
	Davis v. C.B. Fleet

	 	5:07-cv-00599-SMH-MLH
	 	United States District Court
	 

	 	 	 	Western District of Louisiana
	 

	 	 	 	LOUISIANA

22

 

	 	 	 	 	 
	CASE	 	CIVIL ACTION NO.	 	VENUE
	Tidwell v. C.B. Fleet

	 	07-CI-00219
	 	Calloway Circuit Court
	 

	 	 	 	KENTUCKY
	 
	 	 	 	 
	Copas v. C.B. Fleet

	 	2:07-CV-00647
	 	United States District Court
	 

	 	 	 	Southern District of Ohio
	 

	 	 	 	OHIO
	 
	 	 	 	 
	Chrisman v. C.B. Fleet

	 	5-07-CU-165-KSF
	 	United States District Court
	 

	 	 	 	Eastern District of Kentucky
	 

	 	 	 	Central Division of Lexington
	 

	 	 	 	KENTUCKY
	 
	 	 	 	 
	Liner v. C.B. Fleet

	 	6:07-CV-0583
	 	United States District Court
	 

	 	 	 	Western District of Louisiana
	 

	 	 	 	Lafayette Division
	 

	 	 	 	LOUISIANA
	 
	 	 	 	 
	Lange v. C.B. Fleet

	 	CV07-3255 RGK/(MANX)
	 	United Stated District Court
	 

	 	 	 	Central District of California
	 

	 	 	 	CALIFORNIA
	 
	 	 	 	 
	Osborne v. C.B. Fleet

	 	07:3687 JNE/JJG
	 	United States District Court
	 

	 	 	 	District of Minnesota
	 

	 	 	 	MINNESOTA
	 
	 	 	 	 
	Green v. C.B. Fleet

	 	07-80589-CIV-MARRA
	 	United States District Court
	 

	 	 	 	Southern District of Florida
	 

	 	 	 	West Palm Beach Division
	 

	 	 	 	FLORIDA

23

 

EXHIBIT C

[***].

 

			
	***	 	Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

24

Source: [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00131-of-00352.parquet"}, [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00131-of-00352.parquet"}]]