|
|
|
|
Document Preview Commercialization Agreement |
||||
|
|
||||
|
Click "Add to Cart" button to purchase document. |
||||
|
|
||||
|
Title: |
Commercialization Agreement |
|||
|
Entities: |
Discovery Laboratories Inc.; First Union National Bank; Quintiles Transnational Corporation |
|||
|
Date: |
2001 |
|||
|
Size: |
Preview shows 28KB of 115KB total |
|||
|
Price: |
$54 |
|||
|
ID: |
#283700 |
|||
|
|
||||
|
||||
|
|
||||
|
Start of Preview |
||||
COMMERCIALIZATION AGREEMENT
AMONG
DISCOVERY LABORATORIES, INC.
and
QUINTILES TRANSNATIONAL CORPORATION
{PAGE}
TABLE OF CONTENTS
PAGE
ARTICLE 1 SERVICES OVERVIEW; QUINTILES EXCLUSIVITY....................1
1.1 Definitions.................................................1
1.2 Overview; Discovery Engagement of Quintiles.................1
1.3 Quintiles Exclusive Rights..................................1
1.4 Retained Rights by Discovery................................1
ARTICLE 2 COMMITTEES..................................................2
2.1 Joint Commercialization Committee ("JCC")...................2
2.1.1 Formation; Purposes and Principles..........................2
2.1.2 Membership..................................................2
2.1.3 Meetings....................................................3
2.2 Agendas and Minutes for the JCC.............................3
2.3 No Authority to Modify Agreement............................3
ARTICLE 3 MARKETING PLAN; DETERMINATION OF FULLY LOADED COST..........4
3.1 Marketing Plan..............................................4
3.2 Plan Contents...............................................4
3.3 Determination of Fully Loaded Cost..........................4
3.3.1 Baseline for Fully Loaded Cost of Sales Force...............5
ARTICLE 4 QUINTILES RESPONSIBILITIES..................................5
4.1 Covenant to Operate under the Agreement; General Diligence
Requirement.................................................5
4.2 Marketing Services..........................................5
4.2.1 Marketing Representative....................................5
4.3 Hiring Sales Force..........................................5
4.4 Fully Dedicated or Syndicated Sales Force...................6
4.5 Training Requirements.......................................6
4.6 Quintiles Responsibilities..................................6
4.7 Records and Reports Regarding Promotional Activities........7
4.8 Performance Audits..........................................7
ARTICLE 5 DISCOVERY'S RESPONSIBILITIES AND OBLIGATIONS................7
{PAGE}
TABLE OF CONTENTS
(CONTINUED)
Page
5.1 Regulatory Affairs...........................................7
5.2 Minimum Pre-Launch Marketing Commitment......................7
5.3 Minimum Sales Force Expenditure.............................7
5.4 Obligation to Provide Samples................................8
5.5 Sales and Distribution.......................................8
5.5.1 Pricing......................................................8
5.5.2 Booking Sales; Distribution..................................8
5.5.3 Product Returns..............................................8
5.6 Discovery Responsibilites....................................8
ARTICLE 6 TRAINING; ADVERTISING AND PROMOTIONAL MATERIALS..............8
6.1 Training Programs............................................8
6.1.1 Content......................................................8
6.1.2 Cost.........................................................9
6.2 Advertising and Promotional Materials........................9
6.2.1 Creation and Use.............................................9
6.2.2 Ownership; FDA Approval......................................9
6.2.3 Discovery Logos..............................................9
ARTICLE 7 REGULATORY ISSUES AND COMPLAINTS.............................9
7.1 Ownership of Regulatory Filings and Compliance...............9
7.2 Communication with the FDA and Other Regulatory Agencies....10
7.3 New Developments Relating to Product........................10
7.4 Product Recalls.............................................10
7.5 Adverse Event Reporting Procedures..........................10
7.6 Product Inquiries; Complaints...............................10
7.7 Database of Clinical Trial Data.............................11
ARTICLE 8 ACCOUNTING; INVOICING AND PAYMENT...........................11
8.1 Accounting..................................................11
8.2 Payment Schedule ...........................................11
{PAGE}
TABLE OF CONTENTS
(CONTINUED)
Page
8.3 Payment of Invoices.........................................11
8.3.1 Wiring Instructions.........................................11
8.4 Penalty for Late Payment....................................11
8.5 Record Keeping and Financial Audits.........................11
ARTICLE 9 REPRESENTATIVES AND COVENANTS ..............................12
9.1 Mutual Authority............................................12
9.1.1 Corporate Power.............................................12
9.1.2 Due Authorization...........................................12
9.1.3 Binding Agreement...........................................12
9.1.4 Grant of Rights; Maintenance of Agreements..................12
9.1.5 Validity....................................................13
9.2 Conformance with Laws.......................................13
9.3 Rights in Product...........................................13
9.4 Record Maintenance..........................................13
9.5 Firewall....................................................14
9.6 No Use fo Names or Trademarks...............................14
9.7 NDA Filing..................................................14
9.8 Independent Contractor......................................14
ARTICLE 10 CONFIDENTIALITY.............................................14
10.1 Confidential Information....................................14
10.2 Ownership of Data; No License...............................14
10.3 Survival....................................................15
ARTICLE 11 INDEMNIFICATION.............................................15
11.1 Indemnification by Discovery................................15
11.2 Indemnification by Quintiles................................15
11.3 Procedure...................................................15
11.4 No Consequential Damages....................................16
11.5 Discovery Responsibility for Product Description............16
{PAGE}
TABLE OF CONTENTS
(CONTINUED)
Page
11.6 Insurance...................................................16
ARTICLE 12 TERM AND TERMINATION........................................16
12.1 Term........................................................16
12.2 Renewal.....................................................16
12.3 Material Breach.............................................16
12.4 No Product Launch...........................................17
12.5 Bankruptcy..................................................17
12.6 Accrued Rights .............................................17
12.7 Right to Receive Data.......................................18
12.8 Survival....................................................18
ARTICLE 13 SALES FORCE CONVERSION......................................18
13.1 Right to Convert Sales Force................................18
13.2 Transition Plan.............................................18
13.3 Discovery Determination.....................................18
13.4 Proprietary Information.....................................18
ARTICLE 14 DISPUTE RESOLUTION..........................................19
14.1 Disputes....................................................19
14.2 Governing Law...............................................19
ARTICLE 15 MISCELLANEOUS...............................................19
15.1 Return of Materials.........................................19
15.2 Nonsolicitation of Employees................................19
15.3 Entire Agreement; Amendment.................................20
15.4 Force Majeure...............................................20
15.5 Notices.....................................................20
15.6 Consents Not Unreasonably Witheld or Delayed................21
15.7 Maintenance of Records......................................21
15.8 United States Dollars.......................................21
15.9 No Strict Construction......................................21
{PAGE}
TABLE OF CONTENTS
(CONTINUED)
Page
15.10 Assignment..................................................21
15.11 Performance by Affiliates...................................22
15.12 Counterparts................................................22
15.13 Further Actions.............................................22
15.14 Severability................................................22
15.15 Ambiguities.................................................22
15.16 Headings....................................................22
15.18 No waiver...................................................22
{PAGE}
EXHIBIT A
DEFINITIONS.............................................................A-1
EXHIBIT B
MARKETING PLAN OUTLINE..................................................B-1
SCHEDULE I
QUINTILES RESPONSIBILITIES.............................................SI-1
SCHEDULE II
DISCOVERY RESPONSIBILITIES & OBLIGATIONS, DISCOVERY SALES PROJECT.....SII-1
SCHEDULE III
ROLE DEFINITIONS.....................................................SIII-1
1.
{PAGE}
COMMERCIALIZATION AGREEMENT
THIS Commercialization Agreement (the "Agreement") is made effective as of the
10th day of December, 2001 (the "Effective Date"), by and between Discovery
Laboratories, Inc., a corporation organized and existing under the laws of
Delaware, having its principal place of business at 350 South Main Street, Suite
307 Doylestown, PA 18901-4874 ("Discovery"), and Quintiles Transnational Corp.,
a corporation organized and existing under the laws of North Carolina, with its
principal place of business at 4709 Creekstone Drive, Suite 200, Durham, NC
27703 ("Quintiles"), each on behalf of itself and its Affiliates. Discovery and
Quintiles are sometimes referred to herein individually as a "Party" and
collectively as the "Parties."
In consideration of the following covenants, promises and obligations,
Discovery and Quintiles agree as follows.
ARTICLE 1
SERVICES OVERVIEW; QUINTILES EXCLUSIVITY
1.1 Definitions. Capitalized terms used but not defined in the text of
this Agreement shall have the meanings ascribed to them on Exhibit A hereto.
1.2 Overview; Discovery Engagement of Quintiles. Pursuant to this
Agreement, and subject to the terms and conditions of, the Parties shall
collaborate to develop and sustain a market for and promote Surfaxin(R) (the
"Product", as further defined on Exhibit A) in the Territory. Subject to the
terms and conditions of this Agreement, Discovery shall engage Quintiles and/or
Quintiles Affiliates to provide (i) pre- and post-launch marketing activities
("Marketing Services") and (ii) the recruitment, deployment and management of a
dedicated Sales Force ("Sales Force Services" and, together with any Marketing
Services, "Services") for the Product in the Territory, on a preferred basis all
as provided herein. In recognition of the various undertakings provided to
Discovery herein and conditioned upon the performance of the payment obligations
of PharmaBio Development, Inc. ("PharmaBio") as set forth in the (X) Investment
and Commission Agreement (herein so called) and (Y) Loan Agreement (herein so
called) between Discovery and PharmaBio, as appropriate, executed on the date
hereof, Discovery shall pay Quintiles the compensation as set forth herein.
While the Parties have allocated their respective responsibilities under this
Agreement, the Parties intend this program to be broadly collaborative, and seek
to achieve consensus-based decision making to the extent practical, with the
common objective of maximizing the short-term and long-term commercial success
of the Product in the Territory, subject to the terms and conditions of this
Agreement. The Parties further intend to consider appropriate commercialization
constructs with respect to jointly commercializing other neonatal products and
the Product for other indications.
1.3 Quintiles Exclusive Rights. Subject to the terms and conditions of
this Agreement, during the Term, Quintiles (either itself or through an
Affiliate) shall have the exclusive right to provide Sales Force Services for
the Product in the Territory. Except as otherwise provided herein, Quintiles
shall not have any rights with respect to the Product inside or outside of the
Territory.
2.
{PAGE}
1.4 Retained Rights by Discovery. Except as otherwise expressly provided
in Section 1.3, Discovery shall retain all right, title and interest in and to
the Product including, but not limited to, owning all clinical trial data and
designs, protocols, regulatory filings, applications, and approvals for the
Product and data in support thereof, and all manufacturing, distribution of
finished products to designated third party distributor, patent, copyright,
trade secret and trademark rights relating to the Product. Discovery shall be
responsible for conducting all activities for clinical development of the
Product. No license is granted to Quintiles hereunder, either directly or by
implication. Quintiles acknowledges that any study sponsored by or under the
direction of Discovery is a proprietary program of Discovery, containing
trademarks, trade secrets and other intellectual property of Discovery, whether
or not such rights are utilized in the marketing, promotion or sale of the
Product.
ARTICLE 2
COMMITTEES
2.1 Joint Commercialization Committee ("JCC").
2.1.1 Formation; Purposes and Principles. The JCC shall have overall
responsibility for the success of the matters related to the Product in the
Territory as established by this Agreement, including without limitation: (i) to
review and approve the pre- and post-launch Marketing Plan as well as any other
matters required for the sales and promotion of the Product in the Territory,
except to the extent that certain matters are solely the responsibility of a
single Party under this Agreement; (ii) to determine the overall strategy for
marketing, promotion and sales of the Product in the Territory; (iii) to advise,
provide input and determine strategy for future clinical and/or marketing
studies; (iv) to plan and coordinate the Parties' activities hereunder related
to sales and marketing of the Product in the Territory; (v) to adopt and approve
plans and budgets for the Services under this Agreement, including the Marketing
Plan, consistent with the maximization of short-term and long-term profits
derived from the sale of the Product in the Territory and any other activities
related to sales and marketing of the Product in the Territory that the JCC
deems appropriate to achieve the Parties' objectives under this Agreement; (vi)
to request the creation of sales, pricing, and financial reports pertaining to
pre- and post-launch Services and other marketing activities that may be
provided by third parties, and to review such reports in preparation for making
recommendations; (vii) facilitate the flow of information among the Parties,
including coordinating sales activity with manufacturing schedules and
distribution; and (viii) to promptly resolve disputes of the Parties, subject to
Article 14.
2.1.2 Membership. The JCC will be comprised of an equal number of
Discovery and Quintiles representatives, not exceeding three representatives of
each Party unless otherwise mutually agreed. The JCC shall be chaired by one of
the Discovery representatives. The representatives of Discovery shall
collectively be entitled to 1 vote and the representatives of Quintiles shall
collectively be entitled to 1 vote. The JCC shall to the extent practicable seek
to operate by consensus, provided that Discovery (through its chairperson) will
have the tie-breaking vote on all JCC decisions and further provided, however,
that Discovery shall not be entitled to use such tie-breaking vote to
unilaterally amend the Agreement or make decisions materially impacting
3.
{PAGE}
the [***] pursuant to Article 3. To the extent the JCC is not unanimous with
respect to any of the matters set forth in the preceding sentence, the process
outlined in Section 14 of this Agreement shall be followed. Either Party may
appoint, substitute or replace members of the JCC to serve as their
representatives upon notice to the other Party. The Parties shall appoint the
initial members of the JCC within twenty (20) days after the Effective Date.
2.1.3 Meetings. The JCC shall meet in person, by video or by
teleconference (as mutually agreed by the Parties from time to time) on a
quarterly basis or more frequently as may be agreed upon, to exercise its
responsibilities as set forth in Section 2.1.1 of this Agreement, and to review
the progress of the Parties in performing the functions and obligations under
this Agreement. Each Party will be responsible for its own travel and related
costs to attend and host JCC meetings. Location of meetings shall alternate
between Discovery headquarters in Doylestown and Quintiles headquarters in
Research Triangle Park, or at such other locations as may be mutually agreed by
the Parties. In order for a meeting of the JCC to be convened, such meeting must
include at least one (1) committee member of each Party and, provided this
condition is met, an unanimous action taken at such meeting shall have been duly
and validly taken by the JCC. The first meeting of the JCC shall be convened
within [***] from the execution of this Agreement. An immediate task for the JCC
shall be to set forth an initial [***] plan including the setting of a deadline
for the development of the Marketing Plan.
2.2 Agendas and Minutes for the JCC. Unless otherwise decided by the JCC,
each Party will use reasonable efforts to disclose to the chair all proposed
agenda items along with appropriate background or supporting information at
least twenty (20) working days in advance of a JCC meeting. The chair will use
reasonable efforts to will present an agenda with appropriate background or
supporting information at least ten (10) working days in advance of a JCC
meeting. After each meeting of the JCC, the Party whose turn it was hosting such
meeting will prepare, within ten (10) working days after each meeting (whether
held in person, by video or by telecommunication), the minutes reporting in
reasonable detail the actions taken or to be taken by the JCC, or its designees,
the attendees, the status of goals and achievements as well as issues requiring
resolution, and resolutions of previously reported issues, which minutes shall
set forth all pertinent information presented during the meeting in form and
content reasonably acceptable to the other Party and shall be signed by one of
the JCC representatives from each of the Parties.
2.3 No Authority to Modify Agreement. The JCC shall have no authority to
amend or waive compliance with the terms and conditions of this Agreement, or to
approve actions of the Parties which are inconsistent with this Agreement. Any
such amendments and waivers or actions shall be implemented by means of Section
15.3.
Information marked by [***] has been omitted pursuant to a request for
confidential treatment. The omitted portion has been separately filed with the
Securities and Exchange Commission.
4.
{PAGE}
ARTICLE 3
MARKETING PLAN; DETERMINATION OF FULLY LOADED COST
3.1 Marketing Plan. The principal mechanism by which the Parties
coordinate their sales and marketing activities will be a Marketing Plan, to be
prepared and periodically updated as set forth below. The Parties shall take
preparatory steps with respect to the Marketing Plan in accordance with Section
2.1.3 but in any event the Marketing Plan shall be complete within the time set
forth in Section 2.1.3, at which time the JCC shall submit the Marketing Plan to
the respective Chief Executive Officers of the Parties (or their designees). In
preparation for submission thereof, a draft Marketing Plan shall be prepared by
members of the JCC or its designees, and submitted to the Chief Executive
Officers for approval. The initial Marketing Plan will cover the year 2002
through the first year following Product Launch. Periodically thereafter, but no
less frequently than annually (according to a schedule to be established by the
JCC), the JCC shall be responsible for causing the preparation or updating of
the Marketing Plan and submitting to the Chief Executive Officers for approval.
Each Marketing Plan shall include at least a two (2) year projection of Product
plans and budgets.
3.2 Plan Contents. Each Marketing Plan shall include a review of the
marketplace, marketing objectives, strategies, and supporting tactics (with
respective costs, timing, and responsibilities), clinical support plans,
marketing study plans for future clinical and/or marketing studies, Sales Force
effort, pricing, inventory requirements and distribution plans for the Product,
together with sales, revenue and expense forecasts for Product sales in the
Territory. The content of the Marketing Plan shall be determined by the JCC, but
shall generally be in a form consistent with the outline attached hereto as
Exhibit B, and shall include among other items the overall level of anticipated
field sales resource commitments. All budgets contained in the Marketing Plan
shall be based on estimates of the Quintiles Fully Loaded costs and associated
pass-through expenses of the component services contained in the Marketing Plan.
3.3 Determination of Fully Loaded Cost. Quintiles under this Agreement
shall be paid for by Discovery on the basis of the "Fully Loaded Cost" of such
Services. Fully Loaded Cost means the usual and customary fee charged by
Quintiles (or the Quintiles Affiliate, as the case may be) to Third Parties
under a fee for service arrangement for the type of services rendered by it
pursuant to this Agreement (such fee to be based on services of comparable
volume and comparable quality), inclusive of the service provider's customary
profit margin for such volume and quality of service. Fully Loaded Cost shall be
adjusted on an annual basis for increases or decreases caused by cost of living
|
End of Preview |
Home Intelligence Services Subscriptions News About Us