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AMENDED AND RESTATED PROMOTION AGREEMENT

Promotion Agreement

AMENDED AND RESTATED PROMOTION AGREEMENT | Document Parties: Depomed, Inc | Securities Exchange Commission | Watson Pharma, Inc You are currently viewing:
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Depomed, Inc | Securities Exchange Commission | Watson Pharma, Inc

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Title: AMENDED AND RESTATED PROMOTION AGREEMENT
Governing Law: New York     Date: 11/8/2007
Industry: Biotechnology and Drugs     Sector: Healthcare

AMENDED AND RESTATED PROMOTION AGREEMENT, Parties: depomed  inc , securities exchange commission , watson pharma  inc
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Exhibit 10.2

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “***”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24B-2 OF THE EXCHANGE ACT OF 1934.

 

AMENDED AND RESTATED PROMOTION AGREEMENT

 

This AMENDED AND RESTATED PROMOTION AGREEMENT (this “ Agreement ”) is made as of September 21, 2007 (the “ Effective Date ”), by and between Depomed, Inc., a California corporation (“ Depomed ”), and Watson Pharma, Inc., a Delaware corporation (“ Watson ”). Each of Depomed and Watson is referred to herein individually as a “ Party ” and collectively as the “ Parties ”.

 

WHEREAS, Depomed and Watson are parties to that certain Promotion Agreement, dated as of July 18, 2007 related to the Product (the “ Original Agreement ”);

 

WHEREAS, Depomed and Watson desire to amend and restate the Original Agreement as set forth herein;

 

NOW, THEREFORE, in consideration of the foregoing and of the mutual covenants herein contained, the Parties hereto intending to be legally bound hereby agree as follows:

 

ARTICLE I

 

DEFINITIONS

 

As used in this Agreement, the following terms shall have the following meanings:

 

Section 1.1             2007 Plan ” has the meaning set forth in Section 4.5.

 

Section 1.2             Act ” means the United States Federal Food, Drug and Cosmetic Act, 21 U.S.C. 301, et. seq. , as it may be amended from time to time, and the regulations promulgated thereunder, including the Generic Drug Act.

 

Section 1.3             Adverse Drug Experience ” means any “adverse drug experience” as defined or contemplated by 21 C.F.R. 314.80 or 312.32, associated with the Product.

 

Section 1.4             Adverse Drug Experience Report ” means any oral, written or electronic report of any Adverse Drug Experience transmitted to any Person.

 

Section 1.5             Affiliate ” means, with respect to any Person, any other Person that directly or indirectly controls, is controlled by or is under common control with, such first Person. For the purposes of this definition, “ control ” (including, with correlative meanings, the terms “ controlling ,” “ controlled by ” and “ under common control with ”), as applied to any Person, means the possession, directly or indirectly, of the power to direct or cause the direction of the management and policies of that Person, whether through the ownership of voting securities, by contract or otherwise. Notwithstanding the foregoing, for purposes of this Agreement, a Wholesaler Affiliate shall not constitute an Affiliate of Watson.

 

Section 1.6             Agreement ” has the meaning set forth in the preamble to this Agreement

 



 

Section 1.7             Agreement Month ” means each calendar month during the Term (including any partial calendar month in the case of the first and last calendar months of the Term).

 

Section 1.8             Agreement Quarter ” means the Initial Agreement Quarter, each successive period of three months during the Term after the Initial Agreement Quarter and the Final Agreement Quarter.

 

Section 1.9             Alert Report ” is the report per FDA 21 CFR 314.80 Reporting Requirements for postmarketing 15-day “Alert” reports; these are adverse drug experience reports that are both serious and unexpected, and must be reported in writing to the FDA within 15 calendar days.

 

Section 1.10           Annual Plan ” has the meaning set forth in Section 4.5.

 

Section 1.11           cGMP ” shall mean current “Good Manufacturing Practices” as such term is defined from time to time by the FDA or other relevant Governmental Authority having jurisdiction over the manufacture or sale of the Product pursuant to its regulations, guidelines or otherwise.

 

Section 1.12           Channel ” shall mean the long-term sales channel as reported in the Prescriber Data, which includes but is not limited to nursing homes and assisted living facilities.

 

Section 1.13            Co-Chairs ” has the meaning set forth in Section 3.2.

 

Section 1.14           COGS ” means, for a particular period, Depomed’s expenses for cost of goods sold (calculated in accordance with Section 7.2(d)) for Product in the Territory for such period including any expenses incurred directly in connection with the distribution of the Product in the Territory. The COGS as of the Initial Effective Date is set forth on Schedule 1.14.

 

Section 1.15           Confidentiality Agreement ” means that certain Confidentiality Agreement, dated as of February 26, 2007, between Depomed and Watson.

 

Section 1.16           Control ” or “ Controlled ” means, with respect to patents, know-how or other intellectual property rights of any kind, the possession by a Party of the ability to grant a license or sublicense of such rights without the payment of additional consideration and without violating the terms of any agreement or arrangement between such Party and any Third Party.

 

Section 1.17           DDMAC ” means the FDA’s Division of Drug Marketing, Advertising and Communications.

 

Section 1.18           Depomed ” has the meaning set forth in the preamble to this Agreement.

 

Section 1.19           Depomed APL ” means Depomed’s Advertising and Promotional Labeling Committee responsible for reviewing and approving Promotional Materials related to the Product.

 



 

Section 1.20           Depomed Trademarks ” means (a) the ProQuin® trademark, (b) the AcuForm TM trademark, for which Depomed has sought registration for in the United States Patent and Trademark Office, and (c) Depomed®, and, in each case, all related domain names, successor trademarks and other trademark related rights. The Depomed Trademarks are attached hereto as Schedule 1.20 .

 

Section 1.21           Detail ” means an in-person, face-to-face sales presentation of the Product made by a Sales Representative to a Professional, including a P1 Detail or a P2 Detail, and after December 31, 2008, a P3 Detail.

 

Section 1.22           Detail Minimum ” means, for a particular period, the sum of (A) the Urology Detail Minimum for such period, plus (B) the Ob/Gyn Detail Minimum for such period.

 

Section 1.23           Detail Shortfall ” means, for a particular period, the remainder of (A) the Detail Minimum for such period, minus (B) the actual number of PDEs performed during such period. In determining the actual number of PDEs performed during any period (including without limitation for purposes of Section 8.2(a)):  (a) only PDEs performed on Professionals on the Watson Physician List shall be taken into account; and (b) not more than 100% of the P1 Details, 100% of the P2 Details and 100% of the P3 Details (if applicable) required to be performed for such period within each of the Urology Field and the Ob/Gyn Field, as reflected in the applicable Annual Plan(s) or 2007 Plan, shall be taken into account.

 

Section 1.24           Detail Shortfall Ratio ” means, for any period, the quotient of (A) the remainder of (x) the Detail Minimum for such period, minus (y) the Detail Shortfall for such Period (if any), divided by (B) the Detail Minimum for such period. Notwithstanding the foregoing, if the Detail Shortfall is a negative number, the Detail Shortfall Ratio shall be equal to 1.0.

 

Section 1.25           Educational Programs ” means any activities undertaken with respect to the medical education of Professionals and customers regarding the Product and the market or funded by unrestricted educational grants, including educational programs and seminars and continuing medical education materials.

 

Section 1.26           Effective Date ” has the meaning set forth in the preamble to this Agreement.

 

Section 1.27           Esprit ” means Esprit Pharma, Inc., a Delaware corporation.

 

Section 1.28           Esprit License Agreement ” means the Exclusive License and Marketing Agreement, dated as of July 21, 2005, between Depomed and Esprit, as amended.

 

Section 1.29           Esprit Promotional Materials ” has the meaning set forth in Section 4.3(b).

 

Section 1.30           Esprit Termination Agreement ” means the Termination Agreement between Depomed and Esprit, dated as of July 5, 2007, providing for, among other matters, the termination of the Esprit License Agreement.

 

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Section 1.31           Executive Officers ” means the Chief Operating Officer of Depomed (or, if there is no such officer, its President or Chief Executive Officer) and the President, Brand Division of Watson (or, if there is no such officer, its President or Chief Executive Officer).

 

Section 1.32           FDA ” means the United States Food and Drug Administration or any successor agency performing comparable functions in the Territory.

 

Section 1.33           Field ” means the Urology Field and the Ob/Gyn Field, subject to provisions of Sections 7.4 and 8.2(a).

 

Section 1.34           Field Baseline Prescriptions Per Month ” means, subject to Section 8.2(a), the monthly average number of Units of Product included within total prescriptions dispensed during the three-month period beginning on June 1, 2007 and ending on August 31, 2007 in the Territory within the Field (as reflected in the Prescriber Data).

 

Section 1.35           Field Baseline Prescriptions ” means, for any particular period, the result of (A) Field Baseline Prescriptions Per Month, multiplied by (B) the number of months within such period (rounded to the nearest one-tenth of one month).

 

Section 1.36           Field COGS ” means, for a particular period, the result of (A) COGS for such period, multiplied by (B) the Field Ratio for such period.

 

Section 1.37           Field Gross Margin ” means, for a particular period, the result of (A) the remainder of (x) Field Net Sales for such period minus (y) Field COGS for such period, multiplied by (B) the Detail Shortfall Ratio for such period.

 

Section 1.38           Field Net Sales ” means, for a particular period, the result of (A) Net Sales for such period, multiplied by (B) the Field Ratio for such period.

 

Section 1.39           Field Prescription Units ” means, for a particular period, the remainder of (A) the sum of (i) the number of Units of Product included within prescriptions filled during such period in the Territory within the Field, as reflected in the Prescriber Data, plus (ii) the number of Units of Product included within the Channel for such period, as reflected in the Prescriber Data, minus (B) Field Baseline Prescriptions for such period.

 

Section 1.40           Field Ratio ” means, for a particular period, the sum of (A) the quotient of (i) Field Prescription Units for such period, divided by (ii) the number of Units of Product included within Product prescriptions filled during such period in the Territory, as reflected in the Prescriber Data (such quotient being the “ Field Physician Ratio ”), plus (B) the product of (i) the quotient of (x) PA/NP Prescription Units for such period, divided by (y) the number of Units of Product included within Product prescriptions filled during such period in the Territory, as reflected in the Prescriber Data, multiplied by (ii) the Field Physician Ratio.

 

Section 1.41           Final Agreement Quarter ” means the period commencing on the first day following the last full Agreement Quarter during the Term and ending on the last day of the Term.

 

Section 1.42           Force Majeure Event ” has the meaning set forth in Section 15.7.

 

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Section 1.43           GAAP ” has the meaning set forth in Section 7.2(c).

 

Section 1.44           Governmental Authority ” shall mean any court, agency, authority, department, regulatory body or other instrumentality of any government or country or of any national, federal, state, provincial, regional, county, city or other political subdivision of any such government or any supranational organization of which any such country is a member, which has competent and binding authority to decide, mandate, regulate, enforce, or otherwise control the activities of the Parties contemplated by this Agreement.

 

Section 1.45           Initial Agreement Quarter ” means the period commencing on the Effective Date and ending on September 30, 2007.

 

Section 1.46           Initial Effective Date ” means July 18, 2007.

 

Section 1.47           JAMS ” has the meaning set forth in Section 3.5(b).

 

Section 1.48           JSC ” has the meaning set forth in Section 3.1.

 

Section 1.49           Legal Requirements ” means laws, rules and regulations of any Governmental Authority in the Territory.

 

Section 1.50           Minimum Sales Force Level ” has the meaning set forth in Section 4.3(a).

 

Section 1.51           NDA ” means any “new drug application” (as such term is used under the Act) filed or acquired by Depomed or any Affiliate with the FDA with respect to the Product and all subsequent submissions, supplements and amendments thereto, including NDA No. 21-744 filed with the FDA on July 18, 2004 (as such NDA may be amended or supplemented subsequent to the Initial Effective Date).

 

Section 1.52           Net Sales ” means, for a particular period, the gross amount invoiced on sales of Product in the Territory recognized as gross revenue in accordance with GAAP by Depomed, its Affiliates, licensees, sublicensees and assigns to independent, unrelated Third Parties during such period in bona fide arms’ length transactions, less the following deductions, calculated in accordance with GAAP: (a) freight, insurance (but only insurance with respect to shipping the Product), and other transportation charges to the extent added to the sales price and set forth separately as such on the total amount invoiced; (b) any sales, use, value-added, excise taxes or duties or allowances on the selling price of Product; (c) chargebacks, trade, quantity and cash discounts and rebates to the extent customary in the trade, including governmental rebates; (d) allowances or credits, including allowances or credits to customers on account of rejection, defects or returns of the Product entering trade after the Promotion Commencement Date, or because of a retroactive price reduction;  and (f) costs associated with any Product voucher or co-pay assistance programs, to the extent funded by Depomed and approved by Watson. Net Sales shall not include a sale or transfer to an Affiliate, licensee, sublicensee or assign of Watson or Depomed or if done for clinical, regulatory or governmental purposes where no consideration is received; but the resale by such Affiliate, licensee, sublicensee or assign of Watson or Depomed shall be considered a sale of such Product.

 

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Confidential Information, indicated by [***], has been omitted from this filing and filed separately with the Securities Exchange Commission

 

Section 1.53           Ob/Gyn Detail Minimum ” means, for a particular period, [***] of the PDEs required to be performed on Professionals on the Watson Physician List within the Ob/Gyn Field for such Period, as reflected in the Annual Plan(s) or the 2007 Plan (as applicable) for such period and in Sections 4.1(c) – (j) of this Agreement (as applicable).

 

Section 1.54           Ob/Gyn Field ” means Professionals practicing obstetrics and/or gynecology, as so identified by primary AMA specialty, and set forth in the Prescriber Data.

 

Section 1.55           Order ” means any award, decision, injunction, judgment, decree, order, ruling, or verdict entered, issued, made, or rendered by any Governmental Authority or by any arbitrator.

 

Section 1.56           P1 Detail ” means a Detail where the Product is the first item presented.

 

Section 1.57           P2 Detail ” means a Detail where the Product is the second item presented.

 

Section 1.58           P3 Detail ” means a Detail where the Product is the third item presented.

 

Section 1.59            “P A/NP Prescription Units ” means, for a particular period, the number of Units of Product included within Product prescriptions filled during such period in the Territory that result from prescriptions written by Physician Assistants and Nurse Practitioners, as reflected in the Prescriber Data.

 

Section 1.60           PDE ” means a Primary Detail Equivalent, and is equivalent to either of the following:  [***]. Details other than P1 Details, P2 Details and P3 Details will have no effect on any calculation of PDEs. P3 Details will have no effect on the calculation of PDEs prior to December 31, 2008.

 

Section 1.61           PDMA ” means the Prescription Drug Marketing Act, as amended, and the rules and regulations promulgated thereunder.

 

Section 1.62           Person ” means any individual, corporation (including any non-profit corporation), general or limited partnership, limited liability company, joint venture, estate, trust, association, organization, labor union, or other entity or Governmental Authority.

 

Section 1.63           Prescriber Data ” means IMS Health National Prescription Audit data, which measures both total prescriptions dispensed and extended units dispensed (i.e., Units) for Product  in the Territory, separately setting forth the Urology Field, the Ob/Gyn Field, the sales Channel (long term care), and prescriptions attributable to Physician Assistants and Nurse Practitioners during a specified time period, or such data from an alternative source mutually agreed in writing by the Parties.

 

Section 1.64           Product ” means the once-daily oral tablet formulation containing ciprofloxacin as the sole active pharmaceutical ingredient known as ProQuin XR and approved in the Territory under NDA No. 21-744 approved by the FDA on May 19, 2005 (as such NDA may be amended or supplemented subsequent to the Initial Effective Date).

 



 

Section 1.65           Product Complaints ” means any report concerning the quality, purity, quantity, weight, pharmacologic activity, labeling, identity or appearance of the Product.

 

Section 1.66           Professional ” means a physician or other health care practitioner who is permitted by law to prescribe Product.

 

Section 1.67           Promote ,” “ Promotional ” and “ Promotion ” mean, with respect to the Product, any activities undertaken to encourage sales or use of the Product, including Details, product sampling, detail aids, drop-offs, coupons, discount cards, journal advertising, direct mail programs, direct-to-consumer advertising, convention exhibits and all other forms of marketing, advertising, public relations or promotion.

 

Section 1.68           Promotion Commencement Date ” has the meaning set forth in Section 4.1(b).

 

Section 1.69           Promotion Fees ” has the meaning set forth in Section 7.1(a).

 

Section 1.70           Promotional Effort ” has the meaning set forth in Section 4.1(a).

 

Section 1.71           Promotional Materials ” has the meaning set forth in Section 4.4(a).

 

Section 1.72           Proprietary Information ” means any proprietary or confidential information communicated from one Party to the other in connection or relating to this Agreement, which is identified as confidential or proprietary, or which the other Party knows or has reason to know is confidential or proprietary, including the Technology and financial, marketing, business, technical and scientific information or data, information related to Watson’s compensation of its Sales Representatives, information contained within the Annual Plan and 2007 Plan, and the information described in Section 4.6, whether communicated in writing, orally or electronically. Proprietary Information shall not include information that the receiving Party can show through written documentation:

 

(a)            at the time of disclosure, is publicly known;

 

(b)            after the time of disclosure, becomes part of the public domain, except by breach of an agreement between the disclosing Party or any Affiliate thereof and the receiving Party or any Affiliate thereof;

 

(c)            is or was in the possession of the receiving Party or any Affiliate thereof at the time of disclosure by the disclosing Party and was not acquired directly or indirectly from the disclosing Party or any Affiliate thereof or from any other party under an agreement of confidentiality to the disclosing Party or any Affiliate thereof; and

 

(d)            is or was developed by the receiving Party or its Affiliates without use of or reference to the other Party’s Proprietary Information.

 

Section 1.73           Regulatory Approval ” means any and all consents or other authorizations or approvals required from a Governmental Authority to market and sell the Product in the Territory, but excluding any form of reimbursement approval.

 

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Confidential Information, indicated by [***], has been omitted from this filing and filed separately with the Securities Exchange Commission

 

Section 1.74           Sales Representatives ” means sales representatives employed by Watson to Promote the Product, who have been trained and equipped to Promote the Product in accordance with this Agreement. Third Parties may only be engaged as Sales Representatives if they are full-time contractors of Watson, exclusive to Watson, and carry Watson’s business card.

 

Section 1.75           Samples ” has the meaning set forth in Section 6.5.

 

Section 1.76           Serious Adverse Drug Experience ” means any Adverse Drug Experience, including those subject to expedited reporting as defined in the regulations cited below, that is fatal or life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly/birth defect, or is of comparable medical significance or any other event which would constitute a “serious” Adverse Drug Experience pursuant to the terms of 21 C.F.R. 314.80 or 312.32.

 

Section 1.77           Serious Adverse Drug Experience Report ” means any Adverse Drug Experience Report that involves a Serious Adverse Drug Experience.

 

Section 1.78           Tail Gross Margin Percentage ” means the following:

 

(a)                                   if this Agreement terminates on or after September 30, 2010 and before September 30, 2011, [***] (if the Tail Period is eight calendar quarters) or [***] (if the Tail Period is four calendar quarters);

 

(b)                                  if this Agreement terminates on or after September 30, 2011 and before September 30, 2012, [***] (if the Tail Period is eight calendar quarters) or [***] (if the Tail Period is four calendar quarters); or

 

(c)                                   if this Agreement terminates on or after September 30, 2012, [***] (if the Tail Period is eight calendar quarters) or [***] (if the Tail Period is four calendar quarters).

 

If this Agreement terminates only in part with respect to the Ob/Gyn Field or the Urology Field pursuant to Section 8.2(a), the Tail Gross Margin Percentage shall be determined as set forth in clauses (a) – (c) above with respect to each sub-Field upon the termination of this Agreement with respect to that sub-Field).

 

Section 1.79           Tail Period ” means, [***]. Notwithstanding the foregoing, but subject to Section 8.7(c), there shall be no Tail Period unless the Term shall be in effect until at least September 30, 2010. If this Agreement terminates only in part with respect to the Ob/Gyn Field or the Urology Field pursuant to Section 8.2(a), there shall be a separate Tail Period for each sub-Field, and the length of each such Tail Period shall be determined as set forth in the immediately preceding sentence.

 

Section 1.80           Technology ” means all pharmacological, toxicological, preclinical, clinical, technical or other information, data and analysis and know-how relating to the registration, manufacture, packaging, use, marketing and sale of the Product and all proprietary

 



 

Confidential Information, indicated by [***], has been omitted from this filing and filed separately with the Securities Exchange Commission

 

rights relating thereto owned by Depomed or its Affiliates or to which Depomed or its Affiliates has rights so as to be able to license, and relating or pertaining to the Product.

 

Section 1.81           Term ” has the meaning set forth in Section 8.1.

 

Section 1.82           Territory ” means the United States, including its territories and possessions and Puerto Rico.

 

Section 1.83           Third Party ” means any Person other than Watson or Depomed or their respective Affiliates.

 

Section 1.84           Unit ” means a single tablet of the Product.

 

Section 1.85           United States Bankruptcy Code ” shall mean the U.S. Bankruptcy Code, 11 U.S.C. §§ 101, et seq .

 

Section 1.86           Urology Detail Minimum ” means, for a particular period, [***] of the PDEs required to be performed on Professionals on the Watson Physician List within the Urology Field for such Period, as reflected in the Annual Plan(s) or the 2007 Plan (as applicable) for such period and in Sections 4.1(c) – (j) of this Agreement (as applicable).

 

Section 1.87           Urology Field ” means Professionals practicing urology, as so identified by primary AMA specialty and set forth in the Prescriber Data.

 

Section 1.88           Volume Forecast ” has the meaning set forth in Section 6.3.

 

Section 1.89           Watson ” has the meaning set forth in the preamble to this Agreement.

 

Section 1.90           Watson Physician List ” means the list of Professionals to whom the Watson Sales Force presents Details, which list has been agreed to in writing by the Parties prior to the Effective Date (it being understood that such list includes [***]. The Watson Physician List is subject to change from time to time throughout the Term of this Agreement to reflect the then current [***], or as otherwise agreed in writing by the Parties.

 

Section 1.91           Watson Sales Force ” means the field force of Sales Representatives employed or contracted by Watson to Promote the Product in the Territory within the Field.

 

Section 1.92           Watson Trademarks ” means the trademarks set forth on Schedule 1.92 .

 

Section 1.93           Wholesaler Affiliate ” shall mean an affiliate of Watson, substantially all of the business of which consists of the wholesale distribution of pharmaceutical products.

 



 

ARTICLE II

 

GRANT

 

Section 2.1              Grant of Promotion Rights . During the Term, subject to the terms and conditions of this Agreement, Depomed hereby grants to Watson and its Affiliates and Watson and its Affiliates hereby accept a co-exclusive right (together with Depomed and its Affiliates only) to Promote the Product under the Depomed Trademarks in the Territory within the Field and Channel on the terms and subject to the conditions set forth herein.

 

Section 2.2              Sublicense . Watson shall not sublicense, subcontract or otherwise transfer or delegate any of its rights or obligations under this Agreement without the express written consent of Depomed, which consent may not be unreasonably withheld or delayed by Depomed.

 

Section 2.3              Limitation on Promotion .

 

(a)            During the Term of this Agreement, the Watson Sales Force shall not (i) Promote in the Territory any product containing ciprofloxacin hydrochloride, or (ii) Promote in the Territory within the Field any product for the treatment of urinary tract infections, in each case other than the Product.

 

(b)            During the period beginning on the Initial Effective Date and ending on December 31, 2008, Watson shall not, and shall cause if Affiliates not to, Promote in the Territory any product containing ciprofloxacin hydrochloride, other than the Product.

 

Section 2.4              Retention of Rights . Depomed retains and shall retain all proprietary and property interests in the Product until the point of sale or, in the case of Samples, until delivered to Watson as contemplated by Section 6.5. Watson will not have nor represent that it has any control or proprietary or property interests in the Product, except for the licenses and rights specifically granted hereunder. Except as expressly set forth herein, nothing contained herein shall be deemed to grant Watson, by implication, a license or other right or interest in any patent, trademark or other similar property of Depomed or its Affiliates, except as may be necessary for Watson to Promote the Product pursuant to this Agreement. Except as expressly set forth herein, nothing contained herein shall be deemed to grant Depomed, by implication, a license or other right or interest in any patent, trademark or other similar property of Watson or its Affiliates, except as may be necessary for Depomed to Promote the Product pursuant to this Agreement.

 

Section 2.5              Esprit Termination Agreement . Depomed has entered into the Esprit Termination Agreement, which provides for, among other matters, the termination of the Esprit License Agreement and a transition plan providing for the transition of the Product back to Depomed from Esprit that includes specific activities and timelines (the “ Transition Plan ”). Watson has reviewed the Transition Plan. Depomed will use its reasonable best efforts to cause Esprit to comply with its obligations under the Esprit Termination Agreement and the Transition Plan. So long as Depomed uses its reasonable best efforts to cause Esprit to comply with its obligations under the Esprit Termination Agreement and the Transition Plan, Depomed shall not

 

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be in breach of this Agreement as a result of any failure by Esprit to comply with its obligations under the Esprit Termination Agreement or the Transition Plan.

 

ARTICLE III

 

JOINT STEERING COMMITTEE

 

Section 3.1              Establishment . The Parties agree to establish, for the purposes specified herein, a Joint Steering Committee (the “ JSC ”). The Parties acknowledge and agree that the JSC does not have the power to amend, modify or waive any of the terms or conditions of this Agreement.

 

Section 3.2              Joint Steering Committee . The JSC shall be established by the Parties and shall be comprised of four members, two of whom shall be appointed by Depomed and two of whom shall be appointed by Watson. Each Party’s respective initial appointments to the JSC are set forth on Schedule 3.2 hereto. A Party may change any of its representatives at any time if a new person is appointed to any of the foregoing positions by giving written notice to the other Party. The total number of JSC members may be changed by unanimous vote of the JSC from time to time as appropriate; provided , that the JSC shall in all cases be comprised of an equal number of members from each of Depomed and Watson. Watson and Depomed each will designate one representative of such Party to serve as co-chairs of the JSC (the “ Co-Chairs ”). The members appointed to the JSC by each Party shall be employees of such Party and shall be vested with appropriate decision-making authority and power by such Party. The Chief Executive Officers of Watson and Depomed shall not be members of the JSC.

 

Section 3.3              JSC Responsibilities . The responsibilities of the JSC shall be exercised consistent with this Agreement and shall include, but shall not be limited to:

 

(a)            reviewing and approving the Annual Plan as contemplated by Section 4.5 (which approval shall include, without limitation, approval of the number of P1 Details, P2 Details and P3 Details to be performed by the Watson Sales Force for periods after December 31, 2008);

 

(b)            monitoring and reviewing compliance with the 2007 Plan or the Annual Plan;

 

(c)            reviewing Product Promotion strategies and objectives, including Product positioning, messaging and branding;

 

(d)            reviewing Product-related activities associated with managed markets, trade pipeline, manufacturing, and distribution;

 

(e)            reviewing pricing for the Product;

 

(f)             reviewing Product-related regulatory matters;

 

(g)            reviewing sales incentive compensation for the Watson Sales Force related to the Product for periods through December 31, 2008;

 

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(h)            reviewing and approving sales incentive compensation for the Watson Sales Force related to the Product for periods after December 31, 2008;

 

(i)             such other functions as may be mutually agreed upon by the Parties from time to time.

 

For the avoidance of doubt, (i) the JSC shall not have any review or approval rights with respect to any matters relating to the development of the Product and (ii) any decisions of the JSC with respect to matters which relate to Regulatory Approval for the Product shall require Depomed’s prior written consent.

 

Section 3.4              Meetings of the JSC . Meetings of the JSC may be called by the Co-Chairs of the JSC from time to time and, upon no less than five days’ notice, shall otherwise be called when requested by a Party; provided , however , that meetings of the JSC shall be held on at least a monthly basis during the first three months of the Term, and on at least a quarterly basis thereafter. If possible, the meetings shall be held in person or where appropriate, by video or telephone conference. Unless otherwise agreed, the location of any in-person meetings of the JSC shall alternate between the corporate offices of the Parties. The Parties shall determine the form of the meetings. Subject to Section 3.5, decisions shall be made unanimously, each Party having one (1) vote regardless of the number of representatives present or voting; provided , that no such vote shall be valid unless each Party is represented by at least two members either by written proxy or actual presence at the meeting at which the vote is taken. Subject to appropriate confidentiality undertakings where applicable, each Party shall have the right, upon written notice to the other Party, to have present at JSC meetings additional, non-voting participants (not to exceed six such participants at any JSC meeting without the consent of the other Party). Such additional participants shall not be deemed to be, or have any rights or responsibilities of, a member of the JSC. The Parties shall cause their respective representatives on the JSC to use their reasonable efforts to resolve all matters presented to them as expeditiously as possible. Watson shall propose the agenda for each regular meeting and appoint a secretary to the meeting who shall record the minutes of the meeting. Such minutes shall be circulated to the Parties promptly following the meeting for review and comment and for unanimous ratification by both Parties. Each Party shall bear its own travel and related costs incurred in connection with participation in the JSC.

 

Section 3.5              JSC Disputes .

 

(a)            In the event that the JSC is, after a period of ten (10) days, unable to make a decision due to a lack of required unanimity, either Party may submit the matter being considered to the Executive Officers for a joint decision. In such event, either Co-Chair of the JSC, by written notice to the other Party, shall formally request the dispute be resolved by the Executive Officers, specifying the nature of the dispute with sufficient detail to permit adequate consideration by the Executive Officers. The Executive Officers shall diligently and in good faith attempt to resolve the referred dispute expeditiously and, in any event, within fifteen (15) days of receiving such written notification.

 

(b)            In the event that the Executive Officers are unable to reach a resolution of any referred dispute after good faith negotiations during the fifteen (15) day period referred to in

 

4



 

Confidential Information, indicated by [***], has been omitted from this filing and filed separately with the Securities Exchange Commission

 

Section 3.5(a) above and in the event such dispute is not related to compliance with this Agreement, regulatory matters, or the validity, breach or interpretation of this Agreement, either Party may commence mediation within fifteen days after the conclusion of such fifteen (15) day period by providing to the other Party a written request for non-binding mediation, setting forth the subject of the dispute and the relief requested (a “ Mediation Notice ”). The Parties will cooperate with Judicial Arbitration and Mediation Services (“ JAMS ”) and with one another in selecting a mediator from JAMS’ panel of neutrals, and in scheduling the mediation proceedings. The Parties shall endeavor to conclude any mediation under this Section 3.5 within thirty (30) days after delivery by either Party of Mediation Notice. The Parties covenant that they will participate in the mediation in good faith and that they will share equally in its costs; provided that each Party will be responsible for its own attorney’s fees. Either Party may seek equitable relief prior to the mediation to preserve the status quo pending the completion of that process. Except for such an action to obtain equitable relief, neither Party may commence a civil action with respect to the matters submitted to mediation until after the completion of the initial mediation session, or thirty days after delivery of the Mediation Notice, whichever occurs first.

 

(c)            In furtherance of the foregoing provisions of Section 3.5(b), in connection with any mediation conducted as set forth pursuant to Section 3.5(b) with respect to a Detailing or Incentive Compensation Dispute (as defined below), each Party shall submit to the mediator selected pursuant to Section 3.5(b) and to the other Party, at least two weeks in advance of the mediation proceedings, a brief summarizing and supporting its contentions with respect to the dispute for the purpose of facilitating the mediation proceedings. If the Parties fail to resolve any Detailing or Incentive Compensation Dispute following the completion of mediation proceedings with respect to such Detailing or Incentive Compensation Dispute (a “ Detailing or Incentive Compensation Impasse ”), Depomed may terminate this Agreement pursuant to Section 8.2(c). A “ Detailing or Incentive Compensation Dispute ” is any dispute regarding either (i) the incentive compensation payable to the Watson Sales Force in respect of the Product for any period after December 31, 2008 where Watson proposes that less than [***] of the incentive compensation payable to Watson Sales Representatives detailing the Product will be dependent on sales of the Product, or (ii) the number of P1 Details, P2 Details or P3 Details to be performed by Watson for any period after December 31, 2009 where Watson proposes to perform fewer than [***] annual PDEs (on a pro-rated basis for partial years).

 

(d)            The Parties agree that items that are solely reviewed by the JSC, and not both reviewed and approved by the JSC, are not subject to the dispute resolution mechanism set forth in this Section 3.5. Any disputes referred to the Executive Officers for resolution pursuant to this Section 3.5 shall not be subject to any dispute resolution mechanism or procedure unless and until the dispute resolutions procedures set forth in this Section 3.5 are exhausted.

 



 

Confidential Information, indicated by [***], has been omitted from this filing and filed separately with the Securities Exchange Commission

 

ARTICLE IV

 

PRODUCT PROMOTION

 

Section 4.1              Product Promotion .

 

(a)            Subject to applicable Legal Requirements, as well as the provisions of this Agreement, Watson shall, from and after the Promotion Commencement Date, at its sole expense, use commercially reasonable efforts to Promote the Product in the Territory within the Field in accordance with the 2007 Plan or Annual Plan for subsequent years (the “ Promotional Effort ”). For purposes of the preceding sentence, Watson’s commercially reasonable efforts shall mean at least the same degree of effort (including with respect to the reach and frequency of Details) that Watson would use for the Promotion of any of Watson’s products that represent a similar commercial opportunity. The Parties acknowledge that efforts that constitute commercially reasonable efforts may change during the Term. All statements, core selling messages and materials to be utilized by Watson to Promote the Product shall be consistent in all material respects with the Promotional Materials provided or utilized by Depomed. Watson will cause the Watson Sales Force and Watson employees and agents acting on Watson’s behalf to comply with this Agreement and all applicable Legal Requirements in connection with the Promotion of the Product. It is understood, and Watson agrees, that it will be accountable for the acts or omissions of the Watson Sales Force and its employees and agents to the extent such acts or omissions fail to comply with Watson’s obligations under this Agreement.

 

(b)            Watson shall commence (the date of such commencement, the “ Promotion Commencement Date ”) Promotion (including Details by the Watson Sales Force) of the Product in accordance with this Agreement and the performance of the other obligations contained herein that are required to be performed from and after the Promotion Commencement Date as soon as practicable following the date hereof, but no later than October 15, 2007.

 

(c)            During the period beginning on the Promotion Commencement Date and ending four months thereafter, Watson shall perform a P1 Detail on at least [***] of the Professionals on the Watson Physician List within the Urology Field at least once every [***];

 

(d)            During the period beginning on the Promotion Commencement Date and ending on December 31, 2007, Watson shall:

 

(i)             perform an aggregate of at least [***] P1 Details and [***] P2 Details on Professionals on the Watson Physician List within the Urology Field; and

 

(ii)            perform an aggregate of at least [***] P2 Details on Professionals on the Watson Physician List within the Ob/Gyn Field.

 



 

Confidential Information, indicated by [***], has been omitted from this filing and filed separately with the Securities Exchange Commission

 

(e)            During each Agreement Quarter in 2008, Watson shall perform at least [***] P1 Details and [***] P2 Details on Professionals on the Watson Physician List within the Urology Field.

 

(f)             During the Agreement Quarters ending on March 31, 2008 and December 31, 2008, Watson shall perform at least [***] P1 Details on Professionals on the Watson Physician List within the Ob/Gyn Field.

 

(g)            During the Agreement Quarters ending on June 30, 2008 and September 30, 2008, Watson shall perform at least [***] P2 Details on Professionals on the Watson Physician List within the Ob/Gyn Field.

 

(h)            During each Agreement Quarter in 2009, Watson shall perform at least [***] Details on Professionals on the Watson Physician List within the Urology Field, which Details shall be allocated between P1 Details, P2 Details and P3 Details as reflected in the Annual Plan for 2009 approved by the JSC.

 

(i)             During each Agreement Quarter during the Term commencing with the Agreement Quarter beginning on January 1, 2009, Watson shall perform such number of Details on Professionals on the Watson Physician List within the Ob/Gyn Field, and allocated between P1 Details, P2 Details and P3 Details, as is reflected in the Annual Plan approved by the JSC for the applicable year.

 

(j)             During each Agreement Quarter during the Term commencing with the Agreement Quarter beginning on January 1, 2010, Watson shall perform such number of Details on Professionals on the Watson Physician List within the Urology Field, and allocated between P1 Details, P2 Details and P3 Details, as is reflected in the Annual Plan approved by the JSC for the applicable year.

 

(k)            Representations to Customers . Watson will not make any false or misleading representations to Professionals, customers or others regarding Depomed or the Product and will not make any representations, warranties or guarantees with respect to the specifications, features or capabilities of the Product that are not consistent with the applicable then-current FDA approved labeling, package insert or other documentation accompanying or describing the Product, including Depomed’s standard limited warranty and disclaimers. Watson agrees to undertake timely and complete corrective action for any deviations from this Section 4.2, subject to discussion and review by Depomed’s regulatory affairs and quality assurance department.

 

Section 4.2              Watson Sales Force Staffing, Training and Compensation .

 

(a)            Watson agrees that from and after the Promotion Commencement Date, the Watson Sales Force will be staffed with at least [***] full-time Sales Representatives (subject to vacancies consistent with average vacancy rate experienced by Watson across its total sales force) who are actively promoting the Product in accordance with the 2007 Plan or Annual Plan (the “ Minimum Sales Force Level ”). Throughout the remainder of the Term, Watson shall use

 



 

Confidential Information, indicated by [***], has been omitted from this filing and filed separately with the Securities Exchange Commission

 

its commercially reasonable efforts to ensure that the number of Sales Representatives comprising the Watson Sales Force meets or exceeds the Minimum Sales Force Level.

 

(b)            Watson shall be solely responsible for all costs and expenses of compensating its Sales Representatives. Consistent with applicable Legal Requirements, Watson shall pay incentive compensation to Watson Sales Representatives with respect to the Product in accordance with Watson’s incentive compensation; provided , however , that through December 31, 2007, at least [***] and through December 31, 2008, at least [***] of the incentive compensation payable to Watson Sales Representatives detailing the Product will be dependent on sales of the Product. In addition, Depomed may sponsor sales contests or other special incentive compensation, at its own expense, for Watson’s sales force with Watson’s approval. Watson will be responsible for implementing any such contest or incentive compensation.

 

(c)            Watson shall notify its Sales Representatives prior to the Promotion Commencement Date, consistent with its procedures for Watson’s other products, of the total potential incentive compensation for the Product. Promptly after the adoption by Watson of an incentive compensation payment plan with respect to the Product pursuant to, and in compliance with, this Agreement, and promptly after any material amendments to such plan, Watson shall provide to Depomed a summary of the methodology used by Watson to make incentive compensation payments for the Product pursuant to such plan.

 

(d)            The Parties hereby agree that Depomed shall provide to Watson, at no charge to Watson and in quantities agreed by the Parties in writing prior to the Initial Effective Date, previously generated training materials and/or associated electronic copies thereof where applicable. Watson shall furthermore have the option to purchase from Depomed, in sufficient quantities for the Watson Sales Force, additional training materials for the Product created or owned by Depomed, at Depomed’s out-of-pocket cost for such materials. It is anticipated that Watson will utilize Depomed’s training materials in connection with the Product-related training of its Sales Representatives. Any training materials for Watson’s Sales Representatives developed or created by Watson shall be subject to Depomed’s review as Promotional Materials as provided in Section 4.4. Watson shall, at its own expense prior to the Promotion Commencement Date, train its Sales Representatives using such training materials, the other Promotional Materials and such programs as Watson shall deem appropriate that are in compliance with Watson’s obligations hereunder and all other Legal Requirements. Such programs shall include training with respect to reporting Adverse Drug Experiences and technical complaints. After the initial training, Watson shall periodically provide additional training to each of its Sales Representatives, and shall update its training materials as appropriate in connection with such additional training, in accordance with this Section 4.3. Representatives of Depomed may attend, at Depomed’s expense, any Watson training session related to the Product. Watson will notify Depomed at least two weeks in advance of any such training session.

 

Section 4.3              Promotional Materials; Educational Materials .

 

(a)            Subject to Section 4.4(b), The Parties may, each at its sole expense, create prototypes of promotional, advertising, marketing and educational materials (“ Promotional

 



 

Materials ”) to support the Promotional Effort for the Product in the Territory within the Field. Such Promotional Materials may include, by way of example, detailing aids; leave items; journal advertising; appropriate reprints and reprint carriers; and product monographs. All Promotional Materials used by the Watson Sales Force will be subject to the review and approval of the Depomed APL. All Promotional Materials developed by Watson hereunder shall prominently display such Depomed Trademark(s) as shall be specified by Depomed to Watson
























 
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