Common use of Commercial Diligence Clause in Contracts

Commercial Diligence. Following Regulatory Approval of a Licensed Product in the SymBio Territory (and prior to Regulatory Approval with respect to pre-launch activities), SymBio shall use Commercially Reasonable Efforts to Commercialize such Licensed Product in the SymBio Territory. In addition, SymBio shall: (a) use Commercially Reasonable Efforts to perform the activities specified in the Commercialization Plan and use Commercially Reasonable Efforts to meet the dates specified therein; (b) achieve First Commercial Sale of each Licensed Product in the SymBio Territory within [ * ] after Regulatory Approval for such Licensed Product has been obtained provided, however, if SymBio is prevented from meeting the foregoing deadline due to (a) a Force Majeure or requirements of a Regulatory Authority, provided that SymBio gives written notice to Eagle at the time SymBio becomes aware that such Force Majeure or Regulatory Authority requirement is likely to or will prevent SymBio from meeting such deadline, or (b) a failure by Eagle to comply with its obligations under this Agreement or the Supply Agreement, then in each case (a) and (b) herein such deadline shall be extended for the amount of time during which SymBio is so prevented from meeting the applicable deadline; and (c) for a period of [ * ] years following First Commercial Sale of each Licensed Product, ensure that the total number of sales representatives deployed, details performed, and advertising and promotional monies spent by SymBio in aggregate for all Licensed Products (collectively, and not for each Licensed Product) in the SymBio Territory during each semi-annual (6-month) period represents at least [ * ] of the total number of sales representatives, details, and advertising and promotional monies committed by or on behalf of SymBio, directly or indirectly, for its bendamustine products (collectively, the Licensed Product and the Existing SymBio Products) in the SymBio Territory during such semi-annual period; provided, however, that in no event shall SymBio provide less than [ * ] primary, first position details in aggregate for all Licensed Products (collectively, and not for each Licensed Product) each year during such [ * ] year period.

Commercial Diligence. Following Regulatory Approval of a Licensed Within 30 days after the filing for -------------------- regulatory approval in the first Major Market Country for each Product, Durect shall notify ALZA in writing as to its plans for Commercializing such Product in the SymBio Territory. Durect shall diligently pursue regulatory approval and Commercialization of the Products in the Territory. Promptly after obtaining the necessary regulatory approvals (and pricing approval where applicable) in any country of the Territory (and in any event within [* * *] after such approvals) Durect (or its Affiliates or Subcontractors) shall commence and shall continue diligently to Commercialize the Product on a nationwide basis in such country using the same efforts that an established pharmaceutical company normally devotes to its own comparable products, so long as Durect retains Commercialization rights under this Agreement. Without limiting the foregoing, at any time after the [* * *] ALZA may, upon [* * *] prior written notice to Regulatory Approval Durect, identify any country in which a Product is not being commercially sold by Durect, its Affiliates or Subcontractors and **Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC. for which neither Durect or its Affiliates or Subcontractors are, nor have been for at least the preceding [* * *], diligently seeking regulatory approval to Commercialize the Product in such country (the "Identified Country"). ALZA and Durect shall attempt in good faith, for up to [* * *] from the date of such notice, to seek a mutually acceptable means of Commercializing the Product in such Identified Country, which may include both ALZA and Durect negotiating an agreement with a third party. If after such [* * *] no such means has been agreed upon, then ALZA may, by written notice to Durect, terminate the rights of Durect hereunder to Commercialize such Product in such Identified Country. For each Product with respect to pre-launch activitieswhich Durect does not retain Commercialization rights in any particular country ("Terminated Countries"), SymBio ALZA shall use Commercially Reasonable Efforts have the rights to Commercialize such Licensed Product in the SymBio Territory. In addition, SymBio shall: (a) use Commercially Reasonable Efforts to perform the activities specified such Terminated Countries in the Commercialization Plan and use Commercially Reasonable Efforts to meet the dates specified therein; (b) achieve First Commercial Sale of each Licensed Product in the SymBio Territory within [ * ] after Regulatory Approval for such Licensed Product has been obtained provided, however, if SymBio is prevented from meeting the foregoing deadline due to (a) a Force Majeure or requirements of a Regulatory Authority, provided that SymBio gives written notice to Eagle at the time SymBio becomes aware that such Force Majeure or Regulatory Authority requirement is likely to or will prevent SymBio from meeting such deadline, or (b) a failure by Eagle to comply accordance with its obligations under this Agreement or the Supply Agreement, then in each case (a) and (b) herein such deadline shall be extended for the amount of time during which SymBio is so prevented from meeting the applicable deadline; and (c) for a period of [ * ] years following First Commercial Sale of each Licensed Product, ensure that the total number of sales representatives deployed, details performed, and advertising and promotional monies spent by SymBio in aggregate for all Licensed Products (collectively, and not for each Licensed Product) in the SymBio Territory during each semi-annual (6-month) period represents at least [ * ] of the total number of sales representatives, details, and advertising and promotional monies committed by or on behalf of SymBio, directly or indirectly, for its bendamustine products (collectively, the Licensed Product and the Existing SymBio Products) in the SymBio Territory during such semi-annual period; provided, however, that in no event shall SymBio provide less than [ * ] primary, first position details in aggregate for all Licensed Products (collectively, and not for each Licensed Product) each year during such [ * ] year periodSection 11.6.

Commercial Diligence. Following Regulatory Approval of a Licensed Product in the SymBio Territory (and prior to Regulatory Approval with respect to pre-launch activities), SymBio a) Licensee shall use Commercially Reasonable Efforts to Commercialize such Licensed Product in the SymBio Territory. In addition, SymBio shall: (a) use Commercially Reasonable Efforts to perform the activities specified Field in each country or jurisdiction in the Licensed Territory in which it receives Regulatory Approval. After the launch of each Product in the Field in the Licensed Territory, Licensee shall commit at least the same number of sales representatives and the same level of resources and infrastructure in connection with the Commercialization Plan of such Product as are expended by Licensee and use Commercially Reasonable Efforts similarly-sized pharmaceutical companies with similarly-sized infrastructure to meet support and carry out similar operations in connection with the dates specified therein;commercialization of products with similar market potential. Confidential Materials Omitted and Filed Separately with the Securities and Exchange Commission Pursuant to a Request for Confidential Treatment under Rule 24b-2 under the Exchange Act of 1934, as amended. Confidential Portions are marked: [***] (b) Licensee shall achieve First Commercial Sale of each Licensed (i) the Surfaxin Product in and/or Surfaxin LS, as the SymBio Territory within [ * case may be, [***] after Regulatory Drug Approval for such Licensed Product therefor has been obtained providedfrom the appropriate Regulatory Authority (or pricing and reimbursement approval where applicable) [***] to Commercialize the Surfaxin Product and Surfaxin LS, howeveras applicable, if SymBio is prevented from meeting [***]; and (ii) Aerosurf [***] after the foregoing deadline due appropriate Regulatory Authority [***] has approved Licensor’s imported product registration permitting Licensee to (a) a Force Majeure or requirements of a Regulatory AuthorityCommercialize Aerosurf [***], provided that SymBio gives written notice to Eagle at the time SymBio becomes aware that such Force Majeure or Regulatory Authority requirement Aerosurf is likely to or will prevent SymBio from meeting such deadline, or (b) made available [***] by Licensor within a failure by Eagle to comply with its obligations under this Agreement or the Supply Agreement, then in each case (a) and (b) herein such deadline shall be extended for the amount reasonable period of time during which SymBio is so prevented from meeting in advance of the applicable deadline; anddeadlines set forth in this Section 6.6(b). (c) for a period Licensee’s FTE and marketing spend (inclusive of [ * ] years following First Commercial Sale costs of each Licensed sales force, marketing materials, trade show attendance and medical affairs team) in respect of Commercializing the Surfaxin Product, ensure that the total number of sales representatives deployed, details performed, Surfaxin LS and advertising and promotional monies spent by SymBio in aggregate for all Licensed Products (collectively, and not for each Licensed Product) Aerosurf in the SymBio Licensed Territory during each semi-annual (6-month) period represents at least [ * shall be not less than [***] of the total number gross forecasted revenues expected to be derived from the sale of sales representatives, details, and advertising and promotional monies committed by or on behalf of SymBio, directly or indirectly, for its bendamustine products (collectively, the Licensed Product and the Existing SymBio Products) such Products as set forth in the SymBio Territory during such semi-annual period; provided, however, that in no event shall SymBio provide less than [ * ] primary, first position details in aggregate for all Licensed Products (collectively, and not for each Licensed Product) each year during such [ * ] year periodCommercialization Plan.

Commercial Diligence. Following Regulatory Approval of a Licensed Within 30 days after the filing for -------------------- regulatory approval in the first Major Market Country for each Product, Durect shall notify ALZA in writing as to its plans for Commercializing such Product in the SymBio Territory. Durect shall diligently pursue regulatory approval and Commercialization of the Products in the Territory. Promptly after obtaining the necessary regulatory approvals (and pricing approval where applicable) in any country of the Territory (and in any event within [* * *] months after such approvals) Durect (or its Affiliates or Subcontractors) shall commence and shall continue diligently to Commercialize the Product on a nationwide basis in such country using the same efforts that an established pharmaceutical company normally devotes to its own comparable products, so long as Durect retains Commercialization rights under this Agreement. Without limiting the foregoing, at any time after the [* * *] ALZA may, upon [* * *] days prior written notice to Regulatory Approval Durect, identify any country in which a Product is not being commercially sold by Durect, its Affiliates or Subcontractors and **Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC. for which neither Durect or its Affiliates or Subcontractors are, nor have been for at least the preceding [* * *] years, diligently seeking regulatory approval to Commercialize the Product in such country (the "Identified Country"). ALZA and Durect shall attempt in good faith, for up to [* * *] year from the date of such notice, to seek a mutually acceptable means of Commercializing the Product in such Identified Country, which may include both ALZA and Durect negotiating an agreement with a third party. If after such [* * *] period no such means has been agreed upon, then ALZA may, by written notice to Durect, terminate the rights of Durect hereunder to Commercialize such Product in such Identified Country. For each Product with respect to pre-launch activitieswhich Durect does not retain Commercialization rights in any particular country ("Terminated Countries"), SymBio ALZA shall use Commercially Reasonable Efforts have the rights to Commercialize such Licensed Product in the SymBio Territory. In addition, SymBio shall: (a) use Commercially Reasonable Efforts to perform the activities specified such Terminated Countries in the Commercialization Plan and use Commercially Reasonable Efforts to meet the dates specified therein; (b) achieve First Commercial Sale of each Licensed Product in the SymBio Territory within [ * ] after Regulatory Approval for such Licensed Product has been obtained provided, however, if SymBio is prevented from meeting the foregoing deadline due to (a) a Force Majeure or requirements of a Regulatory Authority, provided that SymBio gives written notice to Eagle at the time SymBio becomes aware that such Force Majeure or Regulatory Authority requirement is likely to or will prevent SymBio from meeting such deadline, or (b) a failure by Eagle to comply accordance with its obligations under this Agreement or the Supply Agreement, then in each case (a) and (b) herein such deadline shall be extended for the amount of time during which SymBio is so prevented from meeting the applicable deadline; and (c) for a period of [ * ] years following First Commercial Sale of each Licensed Product, ensure that the total number of sales representatives deployed, details performed, and advertising and promotional monies spent by SymBio in aggregate for all Licensed Products (collectively, and not for each Licensed Product) in the SymBio Territory during each semi-annual (6-month) period represents at least [ * ] of the total number of sales representatives, details, and advertising and promotional monies committed by or on behalf of SymBio, directly or indirectly, for its bendamustine products (collectively, the Licensed Product and the Existing SymBio Products) in the SymBio Territory during such semi-annual period; provided, however, that in no event shall SymBio provide less than [ * ] primary, first position details in aggregate for all Licensed Products (collectively, and not for each Licensed Product) each year during such [ * ] year periodSection 11.6.

Commercial Diligence. Following Promptly after obtaining Regulatory Approval of a Licensed the Product in the SymBio Territory a Jurisdiction (and prior to Regulatory Approval with respect to pre-launch activitiesin any event within [* * *] after such approvals), SymBio NYCOMED (or its Affiliates or Sublicensees) shall commence and shall continue diligently to use Commercially Reasonable Efforts to Commercialize the Product on a nationwide basis in such Licensed Jurisdiction, so long as NYCOMED retains Commercialization rights in such Jurisdiction. Without limiting the foregoing, at any time after the [* * *] of the First Commercial Sale of the Product in the SymBio Territoryfirst Major Market Country, provided that DURECT has made available or supplied to NYCOMED sufficient quantities of Product available for sale within the Major Market Country in accordance with the terms of the Supply Agreement, DURECT may, upon [* * *] calendar days prior written notice to NYCOMED, terminate the rights of NYCOMED hereunder to Commercialize the Product in a Major Market Country in which a Product is not being commercially sold by NYCOMED, its Affiliates or Sublicensees. In addition, SymBio shall: (a) use Commercially Reasonable Efforts to perform at any time after the activities specified in [* * *] of the Commercialization Plan and use Commercially Reasonable Efforts to meet the dates specified therein; (b) achieve First Commercial Sale of each Licensed the Product in the SymBio Territory within [ * ] after Regulatory Approval for such Licensed Product has been obtained provided, however, if SymBio is prevented from meeting the foregoing deadline due to (a) a Force Majeure or requirements of a Regulatory Authorityfirst Major Market Country, provided that SymBio gives written notice DURECT has made available or supplied to Eagle at NYCOMED sufficient quantities of Product available for sale within the time SymBio becomes aware that such Force Majeure or Regulatory Authority requirement is likely to or will prevent SymBio from meeting such deadline, or (b) a failure by Eagle to comply applicable Jurisdiction in accordance with its obligations under this Agreement or the terms of the Supply Agreement, then DURECT may, upon [* * *] calendar days prior written notice to NYCOMED, terminate the rights of NYCOMED hereunder to Commercialize the Product in each case any Jurisdiction other than a Major Market Country in which a Product is not being commercially sold by NYCOMED, its Affiliates or Sublicensees, unless [* * *]. The Jurisdictions with respect to which DURECT has terminated NYCOMED’s rights hereunder (athe “Terminated Countries”) and (b) herein such deadline shall will thereafter no longer be extended for the amount of time during which SymBio is so prevented from meeting the applicable deadline; and (c) for a period of [ * ] years following First Commercial Sale of each Licensed Product, ensure that the total number of sales representatives deployed, details performed, and advertising and promotional monies spent by SymBio in aggregate for all Licensed Products (collectively, and not for each Licensed Product) included in the SymBio Territory during each semi-annual (6-month) period represents at least [ Territory. * ] of * * Certain information on this page has been omitted and filed separately with the total number of sales representatives, details, Securities and advertising and promotional monies committed by or on behalf of SymBio, directly or indirectly, for its bendamustine products (collectively, Exchange Commission. Confidential treatment has been requested with respect to the Licensed Product and the Existing SymBio Products) in the SymBio Territory during such semi-annual period; provided, however, that in no event shall SymBio provide less than [ * ] primary, first position details in aggregate for all Licensed Products (collectively, and not for each Licensed Product) each year during such [ * ] year periodomitted portions.

Commercial Diligence. Following Regulatory Approval of a Licensed Within 30 days after the filing for regulatory approval in the first Major Market Country for each Product, Durect shall notify ALZA in writing as to its plans for Commercializing such Product in the SymBio Territory. Durect shall diligently pursue regulatory approval and Commercialization of the Products in the Territory. Promptly after obtaining the necessary regulatory approvals (and pricing approval where applicable) in any country of the Territory (and prior to Regulatory Approval with respect to pre-launch activities), SymBio shall use Commercially Reasonable Efforts to Commercialize such Licensed Product in the SymBio Territory. In addition, SymBio shall: (a) use Commercially Reasonable Efforts to perform the activities specified in the Commercialization Plan and use Commercially Reasonable Efforts to meet the dates specified therein; (b) achieve First Commercial Sale of each Licensed Product in the SymBio Territory any event within [ * * * ] months after Regulatory Approval for such Licensed approvals) Durect (or its Affiliates or Subcontractors) shall commence and shall continue diligently to Commercialize the Product has been obtained providedon a nationwide basis in such country using the same efforts that an established pharmaceutical company normally devotes to its own comparable products, however, if SymBio is prevented from meeting the foregoing deadline due to (a) a Force Majeure or requirements of a Regulatory Authority, provided that SymBio gives written notice to Eagle at the time SymBio becomes aware that such Force Majeure or Regulatory Authority requirement is likely to or will prevent SymBio from meeting such deadline, or (b) a failure by Eagle to comply with its obligations so long as Durect retains Commercialization rights under this Agreement or Agreement. Without limiting the Supply Agreementforegoing, then to maintain Commercialization rights to a Product in each case (a) and (b) herein Subterritory, Durect must diligently Commercialize such deadline shall be extended for Product in such Subterritory in accordance with the amount of time during which SymBio is so prevented from meeting the Commercialization requirements applicable deadline; and (c) for a period of [ * ] years following First Commercial Sale of each Licensed Product, ensure that the total number of sales representatives deployed, details performed, and advertising and promotional monies spent by SymBio in aggregate for all Licensed Products (collectively, and not for each Licensed Product) to such Subterritory as set forth in the SymBio Territory during each semi-annual (6-month) period represents at least [ * ] of the total number of sales representatives, details, and advertising and promotional monies committed by or on behalf of SymBio, directly or indirectly, for its bendamustine products (collectively, the Licensed Product and the Existing SymBio Products) in the SymBio Territory during such semi-annual periodchart below; provided, however, that Durect shall retain Commercialization rights in no event the entire Territory and it shall SymBio provide less than be deemed to have met the Commercialization requirements in all Subterritories if it has introduced such Product and has met the Commercialization requirements in each Major Market Country (including the obligation to make Product Payments pursuant to Section 6). Subterritory Commercialization Requirements A Durect must Commercialize the Product in [ * * * ] primaryB Durect must Commercialize the Product in [ * * * ] C Durect must Commercialize the Product in [ * * * ] D Durect must Commercialize the Product in [ * * * ] If any time after the [ * * * ], first position details Durect has not met the Commercialization requirements for any Subterritory as set forth above, ALZA may, upon [ * * * ] days prior written notice to Durect, identify any Major Market **Material has been omitted pursuant to a request for confidential treatment and such material has been filed separately with the SEC Country in aggregate such Subterritory listed in the chart above in which a Product is not being commercially sold by Durect, its Affiliates or Subcontractors and for all Licensed Products which neither Durect or its Affiliates or Subcontractors are, nor have been for at least the preceding [ * * * ], diligently seeking regulatory approval to Commercialize the Product in such Major Market Country (collectivelythe "Identified Country"). ALZA and Durect shall attempt in good faith, for up to [ * * * ] from the date of such notice, to seek a mutually acceptable means of Commercializing the Product in such Identified Country, which may include both ALZA and not for each Licensed Product) each year during Durect negotiating an agreement with a third party. If after such [ * * * ] year periodperiod no such means has been agreed upon, then ALZA may, by written notice to Durect, terminate the rights of Durect hereunder to Commercialize such Product in such Subterritory. Notwithstanding the foregoing, Durect shall maintain its sole commercialization rights in any country in such terminated Subterritory where the Product has been introduced for so long as Durect continues diligently to commercialize the Product in such country and to make Product Payments under Section 6 as applicable. For each Product with respect to which Durect does not retain Commercialization rights in the particular countries of the Subterritory ("Terminated Countries"), ALZA shall have the rights to such Product in such Terminated Countries in accordance with Section 11.6.