PROMOTION AGREEMENT
EXHIBIT 10.1
This Promotion Agreement (“Agreement”) is entered into as of February 3, 2010 (“Effective Date”) by
and between XxxxxxXxxxx Pharmaceuticals, Inc. (“MBRK”), a Delaware corporation with offices at 0
Xxxxxxx Xxxxxx, Xxxxx 000, Xxxxxxxx, XX 00000 and XxxxxxXxxxxxxxx.xxx, Inc. (“DD”), a South
Carolina Corporation, with offices at Xxx Xxxx Xxxxxx, Xxxxx 000, Xxxxxxxxx, XX 00000.
WHEREAS DD provides advertising, promotion and marketing services to pharmaceutical companies that
seek to market their products to physicians and other allied medical professionals including
nurses, nurse practitioners, and physician assistants; and
WHEREAS MBRK markets prescription drug products, including its product known as MOXATAG®
(“MOXATAG”) to licensed physicians, nurses, nurse practitioners, and physician assistants in the
United States (“US”) whose clinical practice is consistent with MOXATAG’s approved labeling; and
WHEREAS MBRK seeks to have MOXATAG promoted to as many licensed US physicians, nurse practitioners
and physician assistants whose clinical practice is consistent with MOXATAG’s approved labeling as
is possible and practical.
THEREFORE, for good and valuable consideration, the sufficiency and receipt of which is hereby
acknowledged, the Parties agree that DD will promote MOXATAG to certain US physicians and others as
identified in this Agreement subject to the terms and conditions as set forth below:
Section 1 — Definitions
The terms as used in this Agreement will have the meanings as follows:
| (a) | “Actual DD Target Segment MOXATAG TRx” means the total actual number of MOXATAG
prescriptions filled in the US during the applicable Promotional Measurement Period and
written by DD Target Segment Prescribers as stipulated by the Prescriber Data. |
|
| (b) | “Actual DD Target Segment MOXATAG TRx Tablets” means the average number of tablets
contained in all MOXATAG TRx during the applicable Promotional Measurement Period as
stipulated by the Prescriber Data including the tablet quantities as reported by IMS NPA
weekly EUTRx (tablets) data, multiplied by Actual DD Target Segment MOXATAG TRx. |
|
| (c) | “Change of Control” means the change of control of MBRK, as defined by any of the
following events: A) any third party acquires directly or indirectly the beneficial ownership
of any voting security of MBRK representing fifty percent (50%) of the total voting power of
the then outstanding voting securities of MBRK; B) the consummation of a merger,
consolidation, recapitalization, or reorganization of MBRK with or by a third party which |
would result in fifty percent (50%) or more of the total voting power of MBRK stock being
transferred to a third party; or C) the stockholders or equity holders of MBRK approve a plan
of complete liquidation of MBRK or an agreement for the sale or disposition of all or
substantially all the assets of MBRK. |
| (d) | “Coupons” means those coupons or vouchers provided by MBRK and distributed through a
MBRK designee and whose redemption is tracked by a MBRK designee, and redeemed by patients
filling MOXATAG prescriptions written by DD Target Segment Prescribers. |
|
| (e) | “Cost of Coupon Redemption Amount” means the redemption amount and the costs
associated with printing and processing those Coupons redeemed during the applicable Promotion
Measurement period. |
|
| (f) | “Cost of Samples Amount” means the cost of manufacturing and delivering (including,
without limitation, all applicable freight, packaging and shipping costs) and costs of any
third party vendors used in connection with manufacturing and fulfillment of MOXATAG samples. |
|
| (g) | “Deposit” means that amount which MBRK shall deposit with DD upon the Promotion
Commencement Date and as subject to the adjustment outlined in Section 5. |
|
| (h) | “DD Target Segment Prescribers” means the licensed prescribers as defined in EXHIBIT
1. |
|
| (i) | “Early Termination Fee” means that amount equal to the most recent month’s Promotion
Fee prior to termination, multiplied by the number of unexpired months remaining in the
current year of the Agreement. |
|
| (j) | “End of Agreement Fee” means the fee, in addition to any other amounts due, payable
to DD (when this Agreement is terminated as further described in Section 18(f)) that is equal
to two (2) times the last month’s Promotional Fee earned by DD during the last month of the
Agreement. |
|
| (k) | “FDA” means the federal Food and Drug Administration. |
|
| (l) | “Gross Margin Per Tablet” means the Gross Margin calculated in accordance with GAAP
and which excludes those non-recurring and unusual items that the Parties agree are not
resulting from activities under this Agreement (“GM Adjustment Items”) divided by the actual
number of MOXATAG tablets (as report by IMS Health Rx data) during the applicable Promotional
Period. By way of example, these GM Adjustment Items where appropriate may include inventory
write-offs, changes to prior period reserve balances or foreign exchange gains or losses. MBRK
agrees to provide a summary of any GM Adjustment Items to DD. The calculation of Gross Margin
Per Tablet will be based on U.S. sales of MOXATAG only. For periods after September 30, 2010,
if the Gross Margin per Tablet is less than $3.50, the Parties agree to re-evaluate the
viability of the Agreement and if deemed necessary will use commercially reasonable efforts to
re-negotiate an amendment to the Agreement. |
| (m) | “Gross Margin Per TRx” means the Gross Margin per MOXATAG Rx as calculated in
accordance with GAAP and which exclude GM Adjustment Items. The calculation of Gross
Margin Per TRx will be based on U.S. sales of MOXATAG only. For the period from the Effective
Date through September 30, 2010, the Gross Margin per TRx shall be $36.50. |
|
| (n) | “Intellectual Property Rights” means any and all patents, copyrights, trade secrets,
trademarks, and any and all other intellectual property rights or interests. |
|
| (o) | “Medical Professionals” means licensed nurses, nurse practitioners, and physician
assistants. |
|
| (p) | “MOXATAG” means the prescription drug known as MOXATAG® (amoxicillin
extended-release) Tablets 775 mg, approved by the FDA, having NDC numbers 110442-142-03 and
110442-142-02 which is marketed in the US, including currently and subsequently approved
formulations, strengths, concentrations and delivery mechanisms. |
|
| (q) | “MOXATAG Labeling” shall mean (a) the FDA-approved full prescribing information for
MOXATAG, including any required patient information, and (b) all labels and other written,
printed or graphic matter upon any container, wrapper or any package insert or outsert
utilized with or for MOXATAG. |
|
| (r) | “Parties” means DD and MBRK collectively. |
|
| (s) | “Prescriber Data” means the prescriber data supplied by a nationally recognized
prescription data provider where permitted under federal and state law, which is currently
provided to MBRK by IMS Health. |
|
| (t) | “Promotion Commencement Date” means the first day of the month in which DD commences
its promotion of MOXATAG under this Agreement. |
|
| (u) | “Promotion Fees” means the Promotion Fees payable to DD by MBRK for the promotion
services provided under this Agreement as is calculated by and stipulated in Section 5, which
represent fair market value for such services. |
|
| (v) | “Promotional Materials” shall mean all MBRK-approved and available sales
representative training materials and all MBRK-approved and available written, printed,
graphic, electronic, audio or video matter, including, but not limited to, journal
advertisements, sales aids, formulary binders, reprints, direct mail, direct-to-consumer
advertising, Internet postings, broadcast advertisements and sales reminder aids (for example,
scratch pads, pens and other such items), in each case created by a party or on its behalf and
used or intended for use by DD and MBRK in connection with any promotion of MOXATAG hereunder,
or disease state or indication for which MOXATAG is approved for treatment but excluding
MOXATAG Labeling. |
|
| (w) | “Promotional Measurement Period” means that month during which prescription activity
for MOXATAG is measured. |
|
| (x) | “Territory” shall mean the US, including all US territories, possessions and
protectorates. |
|
| (y) | “Up-Front Payment” means the one-time payment of $50,000 to be made by MBRK to DD
upon execution of this Agreement. |
Section 2 — Term
This Agreement shall commence as of the Effective Date and shall continue in full force and effect
for an initial term of three (3) years from the Promotion Commencement Date, divided into three
one-year periods. Unless terminated in accordance with the provisions of Section 18, this
Agreement shall automatically renew for each subsequent one-year term.
Section 3 — Obligations of DD
3.1 DD will promote MOXATAG to DD Target Segment Prescribers using its full suite of promotion
solutions where DD and MBRK deem appropriate, including but not limited to DD’s a)
eSampling Platform, b) eLearning / eDetailing, c) Educational Email, d) Direct-to-Physician Bulletin Services, e) Physician Portal Promotions, f) Patient Portal Promotions, g) Direct Mail Advertising, h) Coupon Promotions, i) Consumer Condition Content, j) Search Engine Marketing and k) Mini Web Site Promotions where appropriate and with prior written approval from MBRK. MBRK shall have final approval as to the promotion solutions utilized by DD in the promotion of MOXATAG and DD will not deploy any promotion solution without such approval from MBRK. Such promotion solutions are as listed in EXHIBIT 4. In the event that the Parties mutually agree on the provision of additional services beyond those listed in EXHIBIT 4, such additional promotional solutions shall be approved by MBRK and additional Appendices numbered sequentially (1, 2, 3, 4 etc.) setting forth in detail the additional services shall be duly signed by authorized representatives of the Parties and attached to EXHIBIT 4 and incorporated herein. The services contained in EXHIBIT 4 and any related modifications thereto represent those services that are reasonably necessary to accomplish the promotion of MOXATAG. No services shall be provided by DD, or paid for by MBRK, except as agreed to in writing by the Parties.
eSampling Platform, b) eLearning / eDetailing, c) Educational Email, d) Direct-to-Physician Bulletin Services, e) Physician Portal Promotions, f) Patient Portal Promotions, g) Direct Mail Advertising, h) Coupon Promotions, i) Consumer Condition Content, j) Search Engine Marketing and k) Mini Web Site Promotions where appropriate and with prior written approval from MBRK. MBRK shall have final approval as to the promotion solutions utilized by DD in the promotion of MOXATAG and DD will not deploy any promotion solution without such approval from MBRK. Such promotion solutions are as listed in EXHIBIT 4. In the event that the Parties mutually agree on the provision of additional services beyond those listed in EXHIBIT 4, such additional promotional solutions shall be approved by MBRK and additional Appendices numbered sequentially (1, 2, 3, 4 etc.) setting forth in detail the additional services shall be duly signed by authorized representatives of the Parties and attached to EXHIBIT 4 and incorporated herein. The services contained in EXHIBIT 4 and any related modifications thereto represent those services that are reasonably necessary to accomplish the promotion of MOXATAG. No services shall be provided by DD, or paid for by MBRK, except as agreed to in writing by the Parties.
3.2. Notwithstanding any other provision of this Agreement, all Promotional Materials relating to
MOXATAG that will be utilized by DD, as well as the use and placement of such Promotional
Materials, are subject to written approval by MBRK prior to such use. DD agrees to provide draft
and final versions of all Promotional Materials to MBRK for MBRK’s review and approval prior to
DD’s use of such Promotional Materials, provided such materials are developed or modified by DD.
MBRK has the authority to perform the final review of all Promotional Materials developed by DD.
All Promotional Materials are subject to MBRK’s legal, medical and regulatory review and approval
process. DD agrees to make all the necessary changes and/or modifications requested by MBRK. DD
shall not use Promotional Materials for any purpose outside of this Agreement without prior written
authorization from MBRK.
3.3. Notwithstanding any other provision of this Agreement, all MOXATAG sample request forms
(hereinafter “Sample Request Forms”) utilized by DD to document a prescriber’s request for MOXATAG
samples are subject to written approval by MBRK. DD agrees to provide draft and final versions of
all Sample Request Forms to MBRK for MBRK’s review and approval prior to DD’s use of such Sample
Request Forms. MBRK has the authority to perform the final review of all Sample Request Forms
developed by DD or used in conjunct. All Sample Request Forms are subject to MBRK’s legal, medical
and regulatory review and approval process. DD agrees to make all the necessary changes and/or
modifications requested by MBRK. DD shall not use Sample Request Forms for any purpose outside of
this Agreement without prior written authorization from MBRK.
3.4. Notwithstanding any other provision of this Agreement, DD shall not offer or provide any item
to a DD Target Segment Prescriber, without prior written approval by MBRK. The provision of any
items shall be subject to MBRK’s legal, medical and regulatory review and approval process. In the
event that MBRK authorizes the provision of items of nominal value to a DD Target Segment
Prescriber, DD shall track and record the item provided, the associated value, the date of the
transaction, and the recipient DD Target Segment Prescriber, including his or her credentials and
the state in which he or she is licensed, where possible.
3.5 DD shall use commercially reasonable efforts to promote MOXATAG to DD Target Segment
Prescribers and agrees to efficiently perform the services as described in EXHIBIT 4 in compliance
with MBRK’s policies and procedures, and all applicable federal and state laws and regulations,
including, without limitation, federal and state anti-kickback statutes, regulations contained in
21 CFR (Code of Federal Regulations) as they pertain to promotional activity of an FDA-approved
pharmaceutical product and the US Department of Health and Human Services Office of Inspector
General’s (“OIG”) Compliance Program Guidance for Pharmaceutical Manufacturers (2003). DD agrees
that it shall not directly or indirectly offer, pay or transfer anything of value, in cash or
in-kind, to induce DD Target Segment Prescribers to purchase, order, or recommend MOXATAG, nor
shall DD exert undue influence on the medical decision-making of DD Target Segment Prescribers.
3.6. Both Parties agree to assign sufficient resources and personnel to discharge their respective
responsibilities under this Agreement in a timely manner and at all times operating using a
professional standard of work as consistent with industry standards.
3.7. DD shall select and shall have full and complete control of and responsibility for all
actions of its agents, affiliates, officers, directors, employees or subcontractors (hereinafter
“Representatives”) and none of DD’s Representatives are, or shall be deemed to be, the
Representatives of MBRK for any purpose whatsoever by virtue of this Agreement. MBRK has no duty,
liability or responsibility of any kind, to or for the acts or omissions of DD or any of DD’s
Representatives. DD hereby acknowledges and agrees that DD shall cause each of DD’s
Representatives who participate in rendering the services to comply with the terms of this
Agreement. DD hereby acknowledges and agrees that DD is responsible for the failure of any of DD’s
Representatives to comply with the terms of this Agreement.
3.8. DD shall be responsible for obtaining the necessary contracts and releases with or from all
parties whose names, likenesses, testimonials, scripts, musical compositions or similar materials,
assets or rights are used in MBRK’s advertising, promotional, publicity or other materials prepared
and produced by DD under this Agreement, except where MBRK undertakes to be responsible for
obtaining the same. Notwithstanding the foregoing, without the prior written consent of MBRK, DD
is not authorized hereunder or otherwise to enter into any contract or agreement in respect of the
foregoing with a third party if such contract or agreement, directly or indirectly, imposes any
obligations on MBRK.
3.9. All records maintained by DD pertaining to DD’s services to MBRK pursuant to this Agreement
shall be provided to MBRK within 48 hours of MBRK’s request. DD shall also make its records and
other documents relevant to MBRK and this Agreement available for audit or review by MBRK upon
MBRK’s request at a mutually agreed upon time. Upon termination or expiration of this Agreement,
if specifically requested by MBRK, DD shall provide originals or copies of such records to
MBRK.
Section 4 — Costs to Deliver DD Promotion
All costs incurred by DD to deploy its services to promote MOXATAG to DD Target Segment Prescribers
will be the responsibility of DD, except as provided in Section 6.
Section 5 — Up-Front Payment, Deposit and Promotion Fees
5.1. MBRK will pay DD an Up-Front Payment of $50,000 upon execution of this Agreement.
5.2. Additionally, MBRK shall pay a Deposit to DD equal to $100,000 upon the Promotion Commencement
Date. Each month the Parties will review the amount of the Deposit and where necessary MBRK will
make an additional deposit payment to DD in order to maintain a total Deposit with DD of at least
two (2) times the current month’s Promotion Fees. For example, if in a month Promotion Fees are
$105,000, then MBRK will increase the Deposit to two (2) times $105,000, equal to $210,000. The
Parties agree to meet via conference call within five (5) business days of the end of each month to
determine the necessary adjustment, if any, to the Deposit. If it is determined that the Deposit
must be increased, within ten (10) business days of the date upon which the new Deposit is
determined, MBRK shall send to DD the funds necessary to increase the Deposit. Notwithstanding the
above, if during years 2 and 3 of this Agreement, in the event MBRK’s then current annual form 10-K
filed with the SEC does not contain an audit opinion that expresses doubt about MBRK’s ability to
continue as a going concern, then MBRK’s requirement to maintain a Deposit is waived. In all cases
the Deposit amount will be used to settle any outstanding amounts due to DD by MBRK at the end of
the Agreement or at the time the Deposit requirement is waived.
5.3. Additionally, on or before the last day of each month, DD will invoice MBRK for the Promotion
Fees due for the prior month. Such Promotion Fees shall be calculated by:
(a) the following formula for the period from the Effective Date through September 30, 2010:
| (A) | the Actual DD Target Segment MOXATAG TRx for the Promotional Measurement
Period multiplied by: |
||
| (B) | the applicable Gross Margin Per TRx multiplied by: |
||
| (C) | 50%. |
For example: if during the month of March 2010 (a) (A) above was 2,000 TRx and (B) above was
$36.50 then MBRK would be remit $36,500.00 to DD.
OR
(b) the following formula for the period from October 1, 2010 through termination of this
Agreement:
| (A) | the Actual DD Target Segment MOXATAG TRx Tablets for the Promotional
Measurement Period multiplied by: |
||
| (B) | the applicable Gross Margin Per Tablet multiplied by: |
||
| (C) | 50%. |
For example: if during the month of November 2010:
| (A)= | Actual DD Target Segment MOXATAG TRx (5,000) x an average tablet amount for the
month of (9.8 tablets)= 49,000 |
||
| (B)= | 3.65 |
||
| (C)= | 50% |
MBRK would remit $89,425.00 to DD:
These Promotion Fees represent fair market value payment for such services rendered.
The Parties recognize that Promotion Fees are to be settled on a monthly basis which requires the
use of an estimated Gross Margin Per Tablet amount until the actual Gross Margin Per Tablet for an
applicable quarter can be determined. Accordingly, to facilitate the calculation and settlement of
monthly Promotion Fees for periods after September 2010, the Parties agree that the Gross Margin
Per Tablet used to settle the monthly Promotion Fees will be that as calculated using the previous
calendar quarter’s Gross Margin Per Tablet data and current period’s Actual DD Target Segment
MOXATAG TRx. Such Promotion Fees for the three months in any calendar quarter will be subject
to a true-up process which will occur by the 15th of the second month of the following
quarter. By way of example, Promotion Fees for each of the months of April, May and June will be
settled using the Gross Margin Per Tablet amount that has been calculated for the quarter ended
March 31 and will be subject to a true-up process to occur by August 15 with any adjustment to such
Promotion Fees being settled between the parties within 15 days thereafter.
5.4 In the event MBRK shall discontinue detailing prescribers in a territory that is not included
in the then current DD Target Segment Prescribers set forth in EXHIBIT 1 to this Agreement or any
amendments thereto (“New DD Target Segment Prescribers”), the Parties shall negotiate in good faith
the Promotion Fee payable to DD should MBRK desire that DD add those New DD Target Segment
Prescribers to the DD Target Segment Prescribers.
5.5. The Promotion Fees shall be paid to DD by MBRK fifteen (15) days after the receipt of an
invoice from DD by MBRK.
5. 6. The basis for determining the Promotion Fees will be the Prescriber Data provided by MBRK to
DD.
5.7. DD agrees to submit invoices to MBRK at the following address:
Attn: Accounts Payable
XxxxxxXxxxx Pharmaceuticals, Inc.
0 Xxxxxxx Xxxxxx, Xxxxx 000
Xxxxxxxx, XX 00000
XxxxxxXxxxx Pharmaceuticals, Inc.
0 Xxxxxxx Xxxxxx, Xxxxx 000
Xxxxxxxx, XX 00000
Section 6 — Obligations of MBRK
6.1. Subject to the terms of confidentiality set forth in Section 10, MBRK agrees to make
available to DD to the best of its ability the items as stipulated in EXHIBIT 2. These items
include the relevant portions of its marketing and communications plan, approved sales promotion
materials in electronic format where available, sales and training aids relevant to MOXATAG and
promotional items and packages for appropriate licensed physicians, nurses, nurse practitioners and
physician assistants. Additionally, MBRK or its authorized designee shall be responsible for the
provision of MOXATAG samples in response to a prescriber’s request as documented on a Sample
Request Form and MBRK or its authorized vendor shall be solely responsible for sample fulfillment
in quantities agreed to by MBRK. At no time shall DD take physical possession of or title to
MOXATAG samples.
6.2. Notwithstanding any other provision of this Agreement, MBRK shall have the sole right and
authority and in its sole discretion shall take any actions that it deems appropriate with respect
to MOXATAG as would normally be done in accordance with accepted business practices and federal and
state legal requirements to maintain the authorization and/or ability to market MOXATAG in the US,
including, without limitation, the following:
| (a) | manufacturing, storage, and distribution of MOXATAG trade and sample product; |
|
| (b) | the scope and strategies with respect to the marketing and promotion of MOXATAG, including,
without limitation, any labeling or claims in connection therewith; |
|
| (c) | booking sales and distribution of MOXATAG hereunder and performance of related services; |
|
| (d) | handling all aspects of order processing, invoicing and collection, inventory and
receivables; |
|
| (e) | providing customer support, including handling medical queries, and performing other
functions consistent with consumer practice for prescription pharmaceuticals; |
|
| (f) | responding to product and medical complaints relating to MOXATAG; |
|
| (g) | handling all returns of MOXATAG trade and sample product; |
|
| (h) | handling all voluntary recalls and market withdrawals of MOXATAG. In such a situation, DD
will make available to MBRK, upon request, all of DD’s pertinent records on MOXATAG. Any and
all reasonable and documented costs and expenses incurred by DD in the conduct of any such
recall or market withdrawal of MOXATAG shall be reimbursed by MBRK, except to the extent such
recall or market withdrawal was the direct result of the negligence or failure of DD to comply
with its obligations under this Agreement; |
|
| (i) | communicating with any governmental agencies and satisfying their requirements regarding all
regulatory approvals of MOXATAG; including the filing of marketing and promotion materials
approved by MBRK under this Agreement with the FDA in compliance with all FDA pharmaceutical
marketing regulations; |
|
| (j) | reporting adverse reaction reports to US regulatory authorities as required by applicable US
law or regulation; |
| (k) | reporting significant losses and thefts of MOXATAG to the appropriate state and federal
regulatory authorities, as required. In such a situation, DD will make available to MBRK, upon
request, all of DD’s pertinent records on MOXATAG. Any and all reasonable and documented
costs and expenses incurred by DD in the conduct of such activities shall be reimbursed by
MBRK, except to the extent such reporting obligations were the direct result of the negligence
or failure of DD to comply with its obligations under this Agreement; and |
| (l) | negotiating any and all agreements with managed care organizations, payers, wholesalers,
group purchasing organizations, and the like, regarding MOXATAG. |
6.3 Notwithstanding any other provision herein to the contrary, MBRK shall have the sole right
and responsibility for establishing and modifying the terms and conditions with respect to the sale
of MOXATAG, including, without limitation, the price at which MOXATAG will be sold, any discounts
attributable to payments on receivables and distribution of MOXATAG.
6.4. MBRK shall be responsible for the costs of obtaining, tracking, processing, formatting and
reporting Prescriber Data.
6.5. The Cost of Samples Amount and the Cost of Coupon Redemption Amount shall be paid by MBRK.
Section 7 — Independent Contractor
In the performance of DD’s obligations under this Agreement, DD shall at all times act as and be
deemed an independent contractor. Nothing in this Agreement shall be construed to render DD or any
of its employees, agents, or officers, an employee, joint venturer, agent, or partner of MBRK. As
an independent contractor, DD fees and expenses are limited to those expressly stated in this
Agreement. DD is not authorized to assume or create any obligations or responsibilities, express
or implied, on behalf of or in the name of MBRK, except as specifically defined herein. It is
understood that the employees, methods, facilities, and equipment of DD shall at all times be under
DD’s exclusive direction and control. DD shall not participate in MBRK’s fringe benefit plans or
any other compensation or benefit plans MBRK maintains for its own employees.
Section 8 — Representations and Warranties
8.1. MBRK represents and warrants that it has the rights and authorizations required by federal
and state agencies, including but not limited to the FDA granting it the right to market MOXATAG in
the US.
8.2. Each Party represents and warrants that it shall comply in all material respects with any and
all applicable federal, state, and local laws and regulations and industry guidances and standards
applicable to the conduct of business and the execution of any and all marketing and promotional
services or activities pursuant to this Agreement, including but not limited to: the federal
anti-kickback statute, 42 U.S.C. § 1320a-7b(b); federal Food, Drug and Cosmetic Act and relevant
regulations; FDA promotional guidelines; FDA’s Guidance on Industry-Supported Scientific and
Educational Activities (1997); US Department of Health and Human Services OIG Compliance Program
Guidance for Pharmaceutical Manufacturers (2003); the Pharmaceutical
Research and Manufacturers of America (“PhRMA”) Code on Interactions With Healthcare Professionals;
and ethics opinions of the American Medical Association (“AMA”).
8.3. Each Party represents and warrants that it shall comply with any and all applicable federal,
state, and local laws and regulations related to the request and receipt of MOXATAG samples,
including, but not limited to, the Prescription Drug Marketing Act of 1987 (“PDMA”) of 1987, as
amended, and the regulations promulgated thereunder.
8.4. Each Party represents and warrants that it shall comply with any and all applicable federal,
state, and local laws and regulations including, but not limited to, health, safety and security
rules and regulations and all privacy laws and regulations, including but not limited to applicable
state privacy laws and regulations and the privacy requirements set forth in the Health Insurance
Portability and Accountability Act (HIPAA).
8.5. DD represents and warrants that (i) it shall comply with all applicable MBRK policies and
procedures, including MBRK policies governing interactions with physicians and other Medical
Professionals; and (ii) it has the specific industry knowledge, experience and expertise to perform
all of its obligations hereunder in good faith and to industry standards.
8.6. DD represents and warrants that neither DD nor, to DD’s knowledge, any person DD employs in
connection with the services to be performed under this Agreement (i) have been debarred,
suspended, proposed for debarment, declared ineligible or voluntarily excluded from participation
in this transaction by any federal or state law, regulation, or action including, but not limited
to, 21 U.S.C. § 335(a) and (b); (ii) have been convicted of a criminal offense related to
healthcare; and (iii) have been listed by a federal department or agency as debarred, excluded, or
otherwise ineligible for participation in federal healthcare programs as set forth in 42 U.S.C. §
1320a-7, or any similar state law or regulation. DD shall notify MBRK in writing immediately if it
or any person it employs in connection with this Agreement or any obligations performed hereunder,
including any of its employees or other representatives or member of its senior management, is
debarred, is in the process of being debarred, , or if any action, suit, claim, investigation, or
legal or administrative proceeding is pending or is threatened, relating to the debarment or
conviction of DD or any person it employs in connection with this Agreement or any obligations
performed hereunder.
Section 9 — Indemnification
9.1. DD shall indemnify and hold MBRK and its Representatives harmless from and against any
and all claims, losses, demands, causes of action, and any and all related costs and expenses
including, but not limited to reasonable attorneys’ fees, costs, and expenses, incurred by them in
connection with any claim, suit or proceeding (hereinafter “Legal Claims”), arising out of or in
connection with: (1) any negligent or willful act or omission or error of DD, or any of its
Representatives, to the extent such Legal Claim does not arise from the negligent or willful act or
omission of MBRK or any of its Representatives; (2) any violation by DD, or any of its
Representatives of any law, statute, ordinance or regulation; (3) any breach by DD of any of its
representations, warranties or obligations under this Agreement; or (4) statements or
representations by DD, or its Representatives, that are contrary to the MOXATAG Labeling or the
approved Promotional Materials and/or outside the FDA-approved indication(s) for MOXATAG.
9.2. DD warrants that any Promotional Materials developed by DD or its Representatives under this
Agreement, do not infringe, misappropriate or otherwise violate any Intellectual Property Rights of
any third party, and agrees to protect, indemnify and hold harmless MBRK and its Representatives
against any and all claims, losses, demands, causes of action, and any and all related costs and
expenses including, but not limited to reasonable attorneys’ fees, costs, and expenses, incurred by
them in connection with any assertion for such infringement, misappropriation or breach.
9.3. DD warrants that any promotional services rendered by DD or its Representatives under this
Agreement, do not infringe, misappropriate or otherwise violate any Intellectual Property Rights of
any third party, and agrees to protect, indemnify and hold harmless MBRK and its Representatives
against any and all claims, losses, demands, causes of action, and any and all related costs and
expenses including, but not limited to reasonable attorneys’ fees, costs, and expenses, incurred by
them in connection with any assertion for such infringement, misappropriation or breach.
9.4. MBRK warrants that MOXATAG does not infringe, misappropriate or otherwise violate any
Intellectual Property Rights of any third party, and agrees to indemnify and hold harmless DD and
its Representatives against any and all claims, losses, demands, causes of action, and any and all
related costs and expenses including, but not limited to reasonable attorneys’ fees, costs, and
expenses, incurred by them in connection with any assertion for such infringement, misappropriation
or breach.
9.5. MBRK shall indemnify and hold DD harmless from and against any damages, loss or expenses,
including reasonable attorneys’ fees, DD may sustain or incur as the result of any Legal Claims
made, brought, or threatened against DD, arising out of: (1) any negligent or willful act or
omission of MBRK, or any of its Representatives, to the extent that such Legal Claim does not arise
from the negligent or willful act or omission of DD, or any of its Representatives; (2) any adverse
events relating to the use of MBRK products; (3) assertions made in Promotional Materials, provided
MBRK approved such Promotional Materials prior to implementation, including those that DD prepared
for MBRK, and there are no deviations in such Promotional Material from the time MBRK provides DD
with approval of such Promotional Material to the time that such Promotional Material is produced,
printed and/or distributed by DD or on behalf of DD or MBRK; or (4) any breach by MBRK of any of
its representations, warranties or obligations under this Agreement.
9.6. A party seeking indemnification hereunder (an “indemnified party”) shall promptly notify the
other party (the “indemnifying party”) of any claim for which it intends to seek indemnification
pursuant to this Section 9 (an “Indemnified Claim”), upon becoming aware thereof, shall permit the
indemnifying party at the indemnifying party’s cost to defend against such Indemnified Claim and to
control the defense and disposition (including, without limitation, all decisions to litigate,
settle subject to the settlement conditions set forth below, or appeal) of such Indemnified Claim
and shall cooperate in the defense thereof. The indemnified party may, at its option and expense,
have its own counsel participate in any such proceeding and shall cooperate with the indemnifying
party and its insurer in the disposition of any such matter. Except with the prior consent of the
indemnified party, which consent shall not be unreasonably withheld or delayed, the indemnifying
party may not enter into any settlement of any Indemnified Claim unless such settlement includes an
unqualified release of the indemnified party.
9.7. The provisions of this Section 9 shall survive the termination of this Agreement.
9.8. NOTWITHSTANDING THE FOREGOING, NEITHER PARTY SHALL BE LIABLE TO THE OTHER PARTY, UNDER ANY
LEGAL OR EQUITABLE THEORY, FOR ANY INCIDENTAL, SPECIAL OR INDIRECT DAMAGES OF ANY KIND, SUFFERED BY
OR OTHERWISE COMPENSABLE TO SUCH OTHER PARTY, ARISING OUT OF, UNDER OR RELATING TO THIS AGREEMENT,
WHETHER OR NOT ADVISED OF THE POSSIBILITY OF SUCH.
Section 10 —Confidentiality
Both Parties agree to be bound by the Confidentiality Agreement executed by DD and MBRK on December
8, 2009, and which is incorporated by reference as part of this Agreement.
Section 11 — Intellectual Property
11.1. All materials (including Promotional Materials), documents, information, descriptions and
suggestions of every kind supplied to DD by MBRK or any other affiliate of MBRK in connection with
and/or pursuant to this Agreement or relationship established between DD and MBRK (including,
without limitation, any such materials (including Promotional Materials), documents, information,
descriptions and suggestions supplied to DD by MBRK prior to the execution of this Agreement) shall
be the sole and exclusive property of MBRK and MBRK shall have the right to make whatever use it
deems desirable of any such materials, documents, information, descriptions and suggestions. Upon
termination or expiration of this Agreement, DD shall promptly return such items, including all
copies thereof, to MBRK or dispose of such items as directed by MBRK.
11.2. DD agrees that any Intellectual Property Rights associated with Promotional Materials
developed under this Agreement shall be the exclusive property of MBRK.
11.3. Prior to presentation to MBRK of any work or work product produced by DD pursuant to this
Agreement, DD, at its own expense, shall insure that all such work or work product does not violate
or infringe upon the Intellectual Property Rights of any third party.
11.4. All trademarks, service marks or logos developed under this Agreement shall be the exclusive
property of MBRK.
11.5. DD will not have the right to use the name of MBRK, MOXATAG, or MBRK’s trademarks, service
marks, logos, or other similar marks in any manner except with the prior written approval of MBRK;
provided that the foregoing shall not prohibit DD’s use of MBRK’s names or marks in connection with
the performance of the services in a manner consistent with this Agreement. Nothing in this
Agreement shall be construed to assign or license any rights to DD.
Section 12 — Assignment of Work Product
12.1. For good and valuable consideration, the receipt and sufficiency of which is hereby
acknowledged, DD hereby sells, assigns and transfers to MBRK and MBRK shall be the exclusive owner,
assignee, and transferee of the entire right, title and interest, including all renewals for the
entire world, in and to all work performed and work product developed or produced under this
Agreement, including, but not limited to, materials (including Promotional Materials), writings,
documents or other information conceived or reduced to practice or
authored by DD or any of DD Representative’s, either solely or jointly with others, in connection
with and/or pursuant to this Agreement or the relationship established between DD and MBRK or with
information, materials (including Promotional Materials) or facilities of MBRK received or used by
DD or DD’s Representatives during the period in which DD is retained by MBRK.
12.2. In the event DD retains the service of a third party to perform any of DD’s obligations
hereunder DD shall, prior to commencement of any work by such third party, obtain the third party’s
written acknowledgement that all work done by such third party shall be deemed “work made for hire”
and that the copyright in such material shall rest and remain with MBRK, or secure from such third
party written assignment of all right, title and interest in and to the copyright in any material
created by such third party.
Section 13 — Governing Law / Choice of Forum
The Parties agree that the venue for any action, injunctive application or dispute determinable by
a court of law arising out of this Agreement and that this Agreement shall be governed by and
construed and enforced in accordance with the laws of the State of North Carolina, without giving
effect to choice of law or arbitration provisions, and that the federal and state courts therein
shall have jurisdiction over the subject matter and the Parties.
Section 14 — Survival of Certain Provisions
The terms, provisions, representations, and warranties contained in Sections 3.7, 3.9, 9, 10, 11,
12, and 13 of this Agreement by their terms are intended to survive the performance thereof by
either party or both Parties hereunder shall so survive the completion of performance, expiration,
termination or cancellation of this Agreement.
Section 15 — Entire Agreement / Amendments
This Agreement, together with any exhibits and attachments hereto and any orders issued hereunder,
constitutes the entire agreement between the Parties hereto and shall supersede and take the place
of any and all agreements, documents, minutes of meetings or letters concerning the subject matter
hereof that may, prior to the Effective Date, be in existence. Furthermore, this Agreement shall
supersede any and all pre-printed terms on any orders, invoices, and other related documents and
any and all orders issued by DD. This Agreement may only be amended by a statement in writing to
that effect signed by duly authorized representatives of MBRK and DD.
Section 16 — Severability
If any provision of this Agreement is found invalid or unenforceable by a court of competent
jurisdiction, the remainder of this Agreement shall continue in full force and effect. The Parties
shall negotiate in good faith to substitute a valid, legal, and enforceable provision that reflects
the intent of such invalid or unenforceable provision.
Section 17 — Non Waiver
Either party’s failure to enforce any of the terms or conditions herein or to exercise any right or
privilege, or either party’s waiver of any breach under this Agreement shall not be construed to be
a waiver of any other terms, conditions, or privileges, whether of a similar or different type.
Section 18 — Termination and Fees
This Agreement may be terminated as follows:
(a) Either party hereto shall have the right to terminate this Agreement after thirty (30) days
written notice to the other in the event the other is in breach of this Agreement unless the
breaching party cures the breach before the expiration of such period of time. Each such notice
shall set forth in reasonable detail the specifics of the breach.
(b) Either party shall have the right to terminate this Agreement effective upon written notice to
the other party in the event the non-notifying party becomes insolvent or makes an assignment for
the benefit of creditors, or in the event bankruptcy or insolvency proceedings are instituted
against the non-notifying party or on the non-notifying party’s behalf.
(c) Either party shall have the right to terminate this Agreement as per Section 19 below.
(d) MBRK may terminate this Agreement upon 60 days notice for a Change of Control subject to the
Fees outlined in paragraph (f) of this Section 18.
(e) Upon the termination or expiration of this Agreement, all obligations and rights of both MBRK
and DD hereunder shall terminate, except all obligations and rights (i) to make or receive payments
becoming due prior to the date of termination or expiration, (ii) to pay or receive payments for
any damages from any breach of the Agreement and (iii) otherwise provided in Section 14 of this
Agreement. In addition to the foregoing, upon termination or expiration of this Agreement for any
reason, each party shall continue to maintain accurate records necessary to demonstrate compliance
with applicable laws, regulations and guidelines, including, without limitation, records relating
to MOXATAG promotion to DD Target Segment Prescribers.
(f) Termination for Change of Control and Fees — If MBRK terminates this Agreement in the first
year of the Agreement for any reason, then MBRK will pay DD a) an Early Termination Fee plus b) the
End of Agreement Fee. If MBRK terminates the Agreement in years 2 or 3 prior to the period 60 days
before the anniversary date, then MBRK will pay DD only the Early Termination Fee. If the Agreement
is terminated in years 2 or 3 by MBRK providing notice to DD within 60 days of the then current
anniversary date of its intent not to renew, then MBRK will pay DD the End of Agreement Fee but no
Early Termination Fee.
Section 19 — Force Majeure
Each party shall be excused from liability for the failure or delay in performance of any
obligation under this Agreement by reason of any extraordinary, unexpected and/or unavoidable
event, such as acts of God, fire, flood, explosion, earthquake, or other natural forces, war, civil
unrest,
accident, destruction or other casualty, any lack or failure of transportation facilities, any lack
or
failure of supply of raw materials, any strike or labor disturbance, or any other event similar
to those enumerated above. Such excuse from liability shall be effective only to the extent and
duration of the event(s) causing the failure or delay in performance and provided that the party
has not caused such event(s) to occur. Notice by the failing party of such party’s failure or
delay in performance due to force majeure must be given to the other party within ten (10) calendar
days after its occurrence. All delivery dates under this Agreement that have been affected by
force majeure shall be tolled for the duration of such force majeure. In no event shall any party
be required to prevent or settle any labor disturbance or dispute. Notwithstanding the foregoing
and except as otherwise provided in Section 18 above with respect to MBRK’s right to terminate this
Agreement in the event that there is an inability to manufacture MOXATAG due to force majeure
events, should the event(s) of force majeure suffered by a party extend beyond a ninety (90) day
period, the other party may then terminate this Agreement by written notice to the non-performing
party.
Section 20 — Notices
All notices or other communications, which are required or permitted hereunder shall be in writing
and sufficient if delivered personally, sent by overnight courier with tracking capabilities, sent
by first-class, registered or certified mail or sent by confirmed facsimile transmission.
If notices to DD, to:
Xxx Xxxxxxxxx
CEO
XxxxxxXxxxxxxxx.xxx, Inc.
Xxx Xxxx Xxxxxx, Xxxxx 000
Xxxxxxxxx, XX 00000
Telephone: 000-000-0000 xxx.000 Facsimile: 000-000-0000
CEO
XxxxxxXxxxxxxxx.xxx, Inc.
Xxx Xxxx Xxxxxx, Xxxxx 000
Xxxxxxxxx, XX 00000
Telephone: 000-000-0000 xxx.000 Facsimile: 000-000-0000
If notices to MBRK, to:
Xxxx Xxxxxxx
CEO
XxxxxxXxxxx Pharmaceuticals, Inc.
0 Xxxxxxx Xxxxxx — Xxxxx 000
Xxxxxxxx, XX 00000
Telephone: 000-000-0000 Facsimile: 000-000-0000
CEO
XxxxxxXxxxx Pharmaceuticals, Inc.
0 Xxxxxxx Xxxxxx — Xxxxx 000
Xxxxxxxx, XX 00000
Telephone: 000-000-0000 Facsimile: 000-000-0000
With copy to:
Xxxx Xxxx
General Counsel
XxxxxxXxxxx Pharmaceuticals, Inc.
0 Xxxxxxx Xxxxxx — Xxxxx 000
Xxxxxxxx, XX 00000
Telephone: 000-000-0000 Facsimile: 000-000-0000
General Counsel
XxxxxxXxxxx Pharmaceuticals, Inc.
0 Xxxxxxx Xxxxxx — Xxxxx 000
Xxxxxxxx, XX 00000
Telephone: 000-000-0000 Facsimile: 000-000-0000
Section 21 — Disputes/Arbitration
21.1. In the event of any controversy or claim arising from or relating to any provision of this
Agreement, or any term or condition hereof, or the performance by a party of its obligations
hereunder, or its construction or its actual or alleged breach, the Parties will try to settle
their differences amicably between themselves in negotiations between the Parties’ respective
Presidents or their executive level designees. If the dispute has not been resolved to the mutual
satisfaction of the Parties within sixty (60) days after delivery of written notice of such
dispute, either party may request binding arbitration.
21.2. Any dispute which is not resolved by executive level negotiations will be settled by final
and binding arbitration before a single arbitrator in Asheville, NC and such arbitration will be
conducted pursuant to then current rules of arbitration of commercial disputes of the American
Arbitration Association. Judgment upon the award rendered by the arbitrator may be entered in any
court having jurisdiction thereof. The prevailing party shall be entitled to recover from the
losing party reasonable attorney’s fees, expenses and costs. In no event will the arbitrator have
any right or power to award punitive or exemplary damages.
Section 22 — Assignment/Change of Control
This Agreement shall bind the Parties hereto and their successors and assigns, provided that
neither party shall have the right to assign this Agreement or any part thereof to a third party
without the prior written consent of the other party, however such consent will not be unreasonably
withheld.
[Signature Page to Follow]
IN WITNESS WHEREOF, the Parties hereto, each by a duly authorized representative, have executed
this Agreement as of the date first written above.
XxxxxxXxxxxxxxx.xxx, Inc.
|
XxxxxxXxxxx Pharmaceuticals, Inc. | |||||||||||
By:
|
/s/ Xxx Xxxxxxxxx | By: | /s/ Xxxx Xxxxxxx | |||||||||
| Name: | Xxx Xxxxxxxxx | Name: | Xxxx Xxxxxxx | |||||||||
| Title: | CEO | Title: | President & CEO | |||||||||
Date:
|
February 3, 2010 | Date: | February 3, 2010 | |||||||||
[Signature Page to Promotion Agreement]
EXHIBIT 1
TO AGREEMENT BETWEEN
XXXXXXXXXXXXXXX.XXX, INC. AND MBRK PHARMACEUTICALS, INC.
DATED FEBRUARY 3, 2010
XXXXXXXXXXXXXXX.XXX, INC. AND MBRK PHARMACEUTICALS, INC.
DATED FEBRUARY 3, 2010
DD TARGET SEGMENT PRESCRIBERS
The Parties agree that the list of DD Target Segment Prescribers (hereinafter, “DD Target List”)
will be provided to MBRK by DD. MBRK shall have final approval of the DD Target List. MBRK receipt
and approval of the DD Target List shall be documented in writing by the Parties. DD Target
Segment Prescribers shall consist of only those licensed prescribers whose clinical practice is
consistent with MOXATAG’s approved labeling, uses, and indication.
It is anticipated that the DD Target List may exclude at MBRK’s discretion, those prescribers that
MBRK includes it its called upon healthcare practitioners, telemarketing program and as
communicated to DD prior to the DD Target List being approved by MBRK. Any subsequent
modifications to the DD Target List will be as approved in writing by the Parties.
EXHIBIT 2
TO AGREEMENT BETWEEN
XXXXXXXXXXXXXXX.XXX, INC. AND MBRK PHARMACEUTICALS, INC.
DATED FEBRUARY 3, 2010
XXXXXXXXXXXXXXX.XXX, INC. AND MBRK PHARMACEUTICALS, INC.
DATED FEBRUARY 3, 2010
MBRK DELIVERABLES
MBRK agrees to provide DD, to the best of its ability, with the following:
| • | Relevant portions of its MOXATAG marketing and communications plan, |
||
| • | MBRK-approved MOXATAG sales promotion materials in electronic format where available, |
||
| • | MOXATAG sales and training aids, including any eDetailing web site or relevant product
materials, |
||
| • | All applicable MBRK policies and procedures that MBRK requires DD to comply with,
including MBRK policies governing interactions with physicians and other Medical
Professionals, |
||
| • | Analysis where available regarding promotion effectiveness of prior promotions, |
||
| • | Any available market research concerning MOXATAG, |
||
| • | Direct mail collateral pieces as shall be used from time to time by MBRK to promote
MOXATAG to DD Target Segment Prescribers, |
||
| • | Timely review and approval of DD provided draft promotion material for use by DD, |
||
| • | The availability of MOXATAG Coupons and MOXATAG samples and the related fulfillment
services as agreed to in advance by MBRK, |
||
| • | Monthly reporting, detailed by prescriber of redemption of MOXATAG Coupons, and |
||
| • | Monthly and quarterly attendance at status meetings, as appropriate, which may be via
telephone, web based meeting/portal or face to face. |
The Cost of Samples Amount and the Cost of Coupon Amount shall be at the expense of MBRK.
EXHIBIT 3
TO AGREEMENT BETWEEN
XXXXXXXXXXXXXXX.XXX, INC. AND MBRK PHARMACEUTICALS, INC.
DATED FEBRUARY 3, 2010
XXXXXXXXXXXXXXX.XXX, INC. AND MBRK PHARMACEUTICALS, INC.
DATED FEBRUARY 3, 2010
PRESCRIBER DATA
For purposes of this Agreement, Prescriber Data will be the prescription data for the activity
within the U.S. for the USC Level 2 #15151 — Aminopenicillins category, in sufficient detail to
identify periodic prescribing activity of MOXATAG. Such prescriber activity will be the basis for
DD to calculate the Promotion Fees due as per Section 5 for the applicable Promotion Measurement
Period.
EXHIBIT 4
TO AGREEMENT BETWEEN
XXXXXXXXXXXXXXX.XXX, INC. AND MBRK PHARMACEUTICALS, INC.
DATED FEBRUARY 3, 2010
XXXXXXXXXXXXXXX.XXX, INC. AND MBRK PHARMACEUTICALS, INC.
DATED FEBRUARY 3, 2010
PROMOTION SOLUTIONS
DD will provide promotional solutions to promote MOXATAG to DD Target Segment Prescribers as
approved by MBRK. These services may include the following:
eSampling Platform — DD has created an eSampling platform that provides eligible prescribers
with a virtual sample closet. Eligible prescribers will be determined through an analysis of
prescribers selected from the DD Target Segment. Only those prescribers who possess a valid
state license to prescribe MOXATAG and practice in a clinical area consistent with MOXATAG’s
approved labeling will be eligible to receive MOXATAG samples. This closet will provide a
vehicle for these prescribers to order MOXATAG samples utilizing business rules created by
MBRK. DD will promote the availability of samples to agreed upon prescribers and all
fulfillment of samples will be conducted by MBRK’s designated sample fulfillment provider in
accordance with MBRK policies and procedures.
eLearning/eDetailing — DD may create an interactive learning platform that includes content of
both an educational and promotional nature. All content would be consistent with MOXATAG’s
approved labeling and product positioning. The use of quizzes and interactive case
presentations will be created to educate prescribers and promote interest in the eLearning
platform. DD will link and/or incorporate a MOXATAG eDetail into the learning platform, if
available. DD will attempt to use existing approved content for inclusion into the learning
platform to expedite the MBRK approval process. All content will be as approved by MBRK.
Educational Email — DD’s philosophy is to use science to support the promotion of MOXATAG.
Therefore, the promotional program could include a series of educational messages that focus on
clinical results and studies. These messages may be non-branded or partially branded depending
on the nature of the content and shall be consistent with MOXATAG’s approved labeling. New
educational messages may be created and added as a result of ongoing understanding of
prescribers’ attitudes and perceptions. All content shall be approved by MBRK.
Direct-to-Physician Bulletin Services — Promotional emails may be used to communicate the
primary, secondary and tertiary messages to the appropriate DD Target Segment Prescribers. The
appropriate interval and frequency of messaging needed to ensure high response rates and
interest level will be determined in consultation with MBRK.
Promotional emails generally include one or more “calls-to-action” such as online sample
offers, clinical data reprint offers, and links to product website, eLearning Platform and/or a
product eDetail, if available. Promotional emails shall comply with the CAN-SPAM Act of 2003
(15 U.S.C. 7701 et. seq.).
Physician Portal Promotions — DD may place MOXATAG-specific promotion in the DD Professional
site within xxx.XxxxxxXxxxxxxxx.xxx. Prescribers are required to logon or use an existing
electronic communication to enter the site, which allows DD to target specific promotion to
those prescribers whose practice area is consistent with MOXATAG’s approved labeling.
Promotion is in the form of rotating/flash tile ads and text links within the appropriate
disease-state education and MOXATAG sample content areas. All Promotional Materials and their
respective placement shall be approved by MBRK.
Patient Portal Promotions — Where appropriate, DD may place standard banner ads on the DD
website xxx.XxxxxxXxxxxxxxx.xxx that can be made visible to patients researching physicians.
The site can accommodate static and flash banners and business rules developed in conjunction
with MBRK guide the number of ads served based upon the number of banner ads within the
Directory. In addition to the Directory’s landing page, banners can be also served within the
appropriate prescriber search and return pages. Such banner ads will be linked only to those
prescribers whose practice area is consistent with MOXATAG’s approved labeling. All banner ads
and their respective placement shall be approved by MBRK.
Direct Mail Advertising — DD may use print mail to reach selected DD Target Segment
Prescribers. Existing mail creative concepts may be used or if needed, DD may create new mail
concepts in concert with and as approved by MBRK. At XxxxxxXxxxx’x request, all direct mail
advertising will include an opt-out option for recipient prescribers.
Coupon Promotions — DD may deploy a program to promote and distribute Coupons to appropriate
targets as determined by both DD and the MBRK. Coupons can be made available via email
promotion, print mail, site promotion, and within the online sample closet. All coupon
promotion will be as approved by MBRK and shall not be valid for purchases that are reimbursed
in whole or in part by Medicare, Medicaid, or similar federal and state programs), or for
residents of Massachusetts if the purchase is reimbursed by a health care insurer.
Consumer Condition Content — DD may create pages of static disease and condition information
consistent with MOXATAG’s approved labeling that are appropriate for consumers. Pages may
include PDF documents for printing of approved content such as “take along” pieces for patient
office visits. All content will be as approved by MBRK.
Search Engine Marketing — DD may explore the use of specific search terms and phrases that can
be used to promote the product website and/or eLearning platform. Search terms shall be
consistent with MOXATAG’s approved labeling. All search terms and “sponsored link” content
will be as approved by MBRK.
Web Mini Site Promotion — DD may develop and deploy content rich “mini sites” that consist of
static content but offer additional web properties in which to promote MOXATAG. Such mini
sites may also be deployed as part of a search engine strategy as small content rich sites
generally score well within search engine algorithms and place high within the natural return
list. All content will be as approved by MBRK.
DD will not deploy any promotional service relating to MOXATAG without prior written approval from
MBRK. All related Promotional Materials and associated content, as well as the use and placement
of such Promotional Materials, are subject to MBRK’s legal, medical and regulatory review and
approval process.
