Fulfillment; Conversion. (a) For purposes of this Agreement, "best efforts" shall mean that COMPANY shall use reasonable efforts including, to the extent appropriate, pursuing sublicenses or corporate alliances, consistent with those used by comparable pharmaceutical companies in the United States in research and development projects for therapeutic methods or compositions deemed to have commercial value comparable to the Licensed Products. COMPANY's best efforts obligations set forth in this Article 6 and implied by law shall be deemed to have been fulfilled if COMPANY: (i) causes the Phase II Commencement Date with respect to a first Licensed Product to occur by the [ * ] anniversary of the date of this Agreement; and (ii) files an NDA for a Licensed Product by the [ * ] anniversary of the date of this Agreement; and (iii) diligently pursues such Registration; and (iv) commences marketing at least one Licensed Product within [ * ] following such Registration. COMPANY shall be entitled to obtain a maximum of three consecutive extensions of time for meeting each of its obligations to commence Phase II clinical studies or file an NDA, by paying to LICENSORS [ * ] * CONFIDENTIAL TREATMENT REQUESTED CS-92 for a first extension of [ * ] duration, [ * ] for a second extension of [ * ] duration, and [ * ] for a third extension of [ * ] duration. Payment for any such extension must be received by LICENSORS within [ * ] business days following the expiration of the period during which any diligence obligation was required to be met. COMPANY shall provide reports to LICENSORS every [ * ] days following its NDA filing(s) concerning the status of such filing(s) until final approval thereof. Each such report shall describe the status of the COMPANY's NDA and disclose any request for additional information or data received by COMPANY from the FDA during the reporting period and COMPANY's plans for complying with such request. COMPANY shall immediately notify LICENSORS if COMPANY determines that it is unwilling to comply with any FDA requirement the failure with which to comply would result in the given Licensed Product being unapprovable by the FDA (which notice is hereinafter referred to as a "Failure of Diligence Notice"). Upon receipt of such a Failure of Diligence Notice, COMPANY shall be deemed to have failed to meet its diligence obligations, and LICENSORS may thereafter invoke any remedy provided for in this Article without any further notice to COMPANY. (b) In the event COMPANY fails to meet any diligence requirement set forth herein in respect of the Licensed Products, LICENSORS shall have the option in their sole discretion to (i) terminate the Agreement within the entire Licensed Territory or any portion of the Licensed Territory, (ii) convert the license granted in this Agreement into a non-exclusive license within the entire Licensed Territory or any portion of the Licensed Territory, or (iii) * CONFIDENTIAL TREATMENT REQUESTED CS-92 terminate the Agreement within a portion of the Licensed Territory and convert the license granted in this Agreement into a non-exclusive license within a portion of the Licensed Territory. (c) Upon exercise by LICENSORS of any portion of their rights under the preceding Subsection, COMPANY shall deliver to LICENSORS all data, and shall grant to LICENSORS and their sublicensees a non-exclusive, royalty free license under all intellectual property rights in COMPANY's or COMPANY's sublicensees' control and required for regulatory or commercial reasons in order to market any Licensed Product in the country or countries in which termination has occurred. COMPANY shall further provide LICENSORS, promptly upon request, copies of the IND, NDA or other documents required for regulatory approvals for Sale in the United States and any foreign countries provided that such termination has occurred with respect to such countries. COMPANY shall, further permit LICENSORS and any licensee of LICENSORS to cross-reference such filings for such indication and shall sell LICENSORS or LICENSORS' licensees any Licensed Compounds or intermediates used in the synthesis of such Licensed Compounds (and not being used by COMPANY for the synthesis of other compounds) at COMPANY's cost. (d) Prior to exercising any rights under this Section, LICENSORS shall give COMPANY [ * ] notice and shall meet with COMPANY, at COMPANY's request and expense, during such [ * ] period, to discuss any disagreements about whether COMPANY has complied with the requirements of this Section. Upon expiration of such [ * ] period, LICENSORS shall have the right in their sole discretion to proceed with the * CONFIDENTIAL TREATMENT REQUESTED CS-92 exercise of all rights and remedies provided for herein unless the applicable diligence obligation is met during such [ * ] period.
Appears in 1 contract
Fulfillment; Conversion. (a) For purposes of this Agreement, "“best efforts" ” shall mean that COMPANY shall use reasonable efforts including, to the extent appropriate, pursuing sublicenses or and corporate alliances, alliances consistent with those used by comparable pharmaceutical companies in the United States in research and development projects for therapeutic methods or compositions deemed to have commercial value comparable to the Licensed Products. COMPANY's ’s best efforts obligations set forth in this Article 6 and implied by law shall be deemed to have been fulfilled if COMPANY: (i) causes an IND to be filed in a Major Market Country with respect to a Licensed Product for [REDACTED BY EMORY] (each referred to as a [REDACTED BY EMORY]) by the end of the [REDACTED BY EMORY] after the date of this Agreement; and (ii) causes the Phase II Commencement Date with respect to a first Licensed Product for each [REDACTED BY EMORY] [REDACTED BY EMORY] to occur by the [ * ] anniversary end of the date of this Agreement; and (ii) files an NDA for a Licensed Product by the [ * [REDACTED BY EMORY] anniversary of after the date of this Agreement; and (iii) diligently pursues such Registrationfiles an NDA for a Licensed Product for [REDACTED BY EMORY] in a Major Market Country by the end of the [REDACTED BY EMORY] [REDACTED BY EMORY] after the date of this Agreement; and (iv) diligently pursues such Registrations for [REDACTED BY EMORY]; and (v) commences marketing at least one Licensed Product within [ * [REDACTED BY EMORY] following such Registration. COMPANY shall be entitled to obtain a maximum of three consecutive extensions of time for meeting each of its obligations to commence Phase II clinical studies or file an NDA, NDA for [REDACTED BY EMORY] by paying to LICENSORS [ * LICENSOR [REDACTED BY EMORY] * CONFIDENTIAL TREATMENT REQUESTED CS-92 for a first extension of [ * [REDACTED BY EMORY] duration, [ * [REDACTED BY EMORY] for a second extension of [ * [REDACTED BY EMORY] days’ duration, and [ * [REDACTED BY EMORY] for a third extension of [ * [REDACTED BY EMORY] duration. Payment for any such extension must be received by LICENSORS LICENSOR within [ * [REDACTED BY EMORY] business days following the expiration of the period during which any diligence obligation was required to be met. COMPANY shall provide reports to LICENSORS LICENSOR every [ * [REDACTED BY EMORY] days following its NDA filing(s) concerning the status of such filing(s) until final approval thereof. Each such report shall describe the status of the COMPANY's ’s NDA and disclose any request for additional information or data received by COMPANY from the FDA during the reporting period and COMPANY's ’s plans for complying with such request. COMPANY shall immediately notify LICENSORS LICENSOR if COMPANY determines that it is unwilling to comply with any FDA requirement the failure with which to comply would result in the given Licensed Product being * Confidential Treatment Requested 18 unapprovable by the FDA (which notice is hereinafter referred to as a "“Failure of Diligence Notice"”). Upon receipt of such a Failure of Diligence Notice, COMPANY shall be deemed to have failed to meet its diligence obligations, and LICENSORS LICENSOR may thereafter invoke any remedy provided for in this Article without any further notice to COMPANY.
(b) In the event COMPANY fails to meet any diligence requirement set forth herein in respect of the a Licensed ProductsProduct for a given [REDACTED BY EMORY], LICENSORS LICENSOR shall have the option in their its sole discretion to (i) terminate the Agreement within the entire Licensed Territory or any portion of the Licensed TerritoryTerritory for such [REDACTED BY EMORY], (ii) convert the license granted in this Agreement into a non-exclusive license within the entire Licensed Territory or any portion of the Licensed TerritoryTerritory for such Major Indication, or (iii) * CONFIDENTIAL TREATMENT REQUESTED CS-92 terminate the Agreement within a portion of the Licensed Territory and convert the license granted in this Agreement into a non-exclusive license within a portion of the Licensed TerritoryTerritory for such [REDACTED BY EMORY].
(c) Upon exercise by LICENSORS LICENSOR of any portion of their its rights under the preceding SubsectionSubsection with respect to a given [REDACTED BY EMORY], COMPANY shall deliver to LICENSORS LICENSOR all data, and shall grant to LICENSORS LICENSOR and their its sublicensees a non-exclusive, royalty free license under all intellectual property rights in COMPANY's ’s or COMPANY's ’s sublicensees' ’ control and required for regulatory or commercial reasons in order to market any Licensed Product in the country or countries in which termination has occurredoccurred for such [REDACTED BY EMORY]. COMPANY shall further provide LICENSORSLICENSOR, promptly upon request, copies of the any IND, NDA or other documents required for regulatory approvals for Sale in the United States and any foreign countries for such [REDACTED BY EMORY] and any other data and information otherwise necessary or useful in connection with the development thereof provided that such termination has occurred with respect to such countries. COMPANY shall, further permit LICENSORS LICENSOR and any licensee of LICENSORS LICENSOR to cross-reference such filings for such indication [REDACTED BY EMORY] and shall sell LICENSORS LICENSOR or LICENSORS' LICENSOR’s licensees any Licensed Compounds or intermediates used in the synthesis of such Licensed Compounds (and not being used by COMPANY for the synthesis of other compounds) at COMPANY's ’s cost.
(d) Prior to exercising any rights under this Section, LICENSORS LICENSOR shall give COMPANY [ * [REDACTED BY EMORY] notice and shall meet with COMPANY, at COMPANY's ’s request and expense, during such [ * [REDACTED BY EMORY] period, to discuss any disagreements about whether COMPANY has complied with the requirements of this Section. Upon expiration of such [ * [REDACTED BY EMORY] period, LICENSORS LICENSOR shall have the right in their its sole discretion to proceed with the * CONFIDENTIAL TREATMENT REQUESTED CS-92 exercise of all rights and remedies provided for herein unless the applicable diligence obligation is met during such [ * [REDACTED BY EMORY] period.
Appears in 1 contract
Sources: License Agreement (Pharmasset Inc)
Fulfillment; Conversion. (a) For purposes of this Agreement, "best efforts" shall mean that COMPANY shall use reasonable efforts including, to the extent appropriate, pursuing sublicenses or corporate alliances, consistent with those used by comparable pharmaceutical companies in the United States in research and development projects for therapeutic methods or compositions deemed to have commercial value comparable to the Licensed Products. COMPANY's best efforts obligations set forth in this Article 6 and implied by law shall be deemed to have been fulfilled if COMPANY: (i) causes the Phase II Commencement Date with respect to a first Licensed Product to occur for [ * ] (the "First Indication") to occur by the [ * ] anniversary of the date of this Agreement; and (ii) files an NDA for a Licensed Product for the First Indication by the [ * ] anniversary of the date of this Agreement; and (iii) diligently pursues such Registrationcauses the Phase II Commencement Date with respect to [ * ] (the "Second Indication") to occur by the [ * ] anniversary of the date of this Agreement; and (iv) files the NDA for a Licensed Product for the Second Indication by the * CONFIDENTIAL TREATMENT REQUESTED DAPD [ * ] anniversary of the date of this Agreement; and (v) diligently pursues such Registrations for both indications; and (vi) commences marketing at least one Licensed Product within [ * ] following such Registration. COMPANY shall be entitled to obtain a maximum of three consecutive extensions of time for meeting each of its obligations to commence Phase II clinical studies or file an NDA, NDA for [ * ] by paying to LICENSORS [ * ] * CONFIDENTIAL TREATMENT REQUESTED CS-92 for a first extension of [ * ] duration, [ * ] for a second extension of [ * ] duration, and [ * ] for a third extension of [ * ] duration. Payment for any such extension must be received by LICENSORS within [ * ] business days following the expiration of the period during which any diligence obligation was required to be met. COMPANY shall provide reports to LICENSORS every [ * ] days following its NDA filing(s) concerning the status of such filing(s) until final approval thereof. Each such report shall describe the status of the COMPANY's NDA and disclose any request for additional information or data received by COMPANY from the FDA during the reporting period and COMPANY's plans for complying with such request. COMPANY shall immediately notify LICENSORS if COMPANY determines that it is unwilling to comply with any FDA requirement the failure with which to comply would result in the given Licensed Product being unapprovable by the FDA (which notice is hereinafter referred to as a "Failure of Diligence Notice"). Upon receipt of such a Failure of Diligence Notice, COMPANY shall be deemed to have failed to meet its diligence obligations, and LICENSORS may thereafter invoke any remedy provided for in this Article without any further notice to COMPANY.. * CONFIDENTIAL TREATMENT REQUESTED 28 DAPD
(b) In the event COMPANY fails to meet any diligence requirement set forth herein in respect of the a Licensed ProductsProduct for a given indication, LICENSORS shall have the option in their sole discretion to (i) terminate the Agreement within the entire Licensed Territory or any portion of the Licensed TerritoryTerritory for such indication, (ii) convert the license granted in this Agreement into a non-exclusive license within the entire Licensed Territory or any portion of the Licensed TerritoryTerritory for such indication, or (iii) * CONFIDENTIAL TREATMENT REQUESTED CS-92 terminate the Agreement within a portion of the Licensed Territory and convert the license granted in this Agreement into a non-exclusive license within a portion of the Licensed TerritoryTerritory for such indication.
(c) Upon exercise by LICENSORS of any portion of their rights under the preceding SubsectionSubsection with respect to a given indication, COMPANY shall deliver to LICENSORS all data, and shall grant to LICENSORS and their sublicensees a non-exclusive, royalty free license under all intellectual property rights in COMPANY's or COMPANY's sublicensees' control and required for regulatory or commercial reasons in order to market any Licensed Product in the country or countries in which termination has occurredoccurred for such indication. COMPANY shall further provide LICENSORS, promptly upon request, copies of the IND, NDA or other documents required for regulatory approvals for Sale in the United States and any foreign countries for such indication provided that such termination has occurred with respect to such countries. COMPANY shall, further permit LICENSORS and any licensee of LICENSORS to cross-reference such filings for such indication and shall sell LICENSORS or LICENSORS' licensees any Licensed Compounds or intermediates used in the synthesis of such Licensed DAPD Compounds (and not being used by COMPANY for the synthesis of other compounds) at COMPANY's cost.
(d) Prior to exercising any rights under this Section, LICENSORS shall give COMPANY [ * ] notice and shall meet with COMPANY, at COMPANY's request and expense, during such [ * ] period, to discuss any disagreements about whether COMPANY has complied with the requirements of this Section. Upon expiration of such [ * ] period, LICENSORS shall have the right in their sole discretion to proceed with the * CONFIDENTIAL TREATMENT REQUESTED CS-92 exercise of all rights and remedies provided for herein unless the applicable diligence obligation is met during such [ * ] period.
Appears in 1 contract
Fulfillment; Conversion. (a) For purposes of this Agreement, "best efforts" shall mean that COMPANY shall use reasonable efforts including, to the extent appropriate, pursuing sublicenses or and corporate alliances, alliances consistent with those used by comparable pharmaceutical companies in the United States in research and development projects for therapeutic methods or compositions deemed to have commercial value comparable to the Licensed Products. COMPANY's best efforts obligations set forth in this Article 6 and implied by law shall be deemed to have been fulfilled if COMPANY: (i) causes an IND to be filed in a Major Market Country with respect to a Licensed Product for [ * ] (each referred to as a [ * ]) by the end of * Confidential Treatment Requested the [ * ] after the date of this Agreement; and (ii) causes the Phase II Commencement Date with respect to a first Licensed Product for each [ * ] [ * ] to occur by the [ * ] anniversary end of the date of this Agreement; and (ii) files an NDA for a Licensed Product by the [ * ] anniversary of after the date of this Agreement; and (iii) diligently pursues such Registrationfiles an NDA for a Licensed Product for [ * ] in a Major Market Country by the end of the [ * ] [ * ] after the date of this Agreement; and (iv) diligently pursues such Registrations for [ * ]; and (v) commences marketing at least one Licensed Product within [ * ] following such Registration. COMPANY shall be entitled to obtain a maximum of three consecutive extensions of time for meeting each of its obligations to commence Phase II clinical studies or file an NDA, NDA for [ * ] by paying to LICENSORS LICENSOR [ * ] * CONFIDENTIAL TREATMENT REQUESTED CS-92 for a first extension of [ * ] duration, [ * ] for a second extension of [ * ] days' duration, and [ * ] for a third extension of [ * ] duration. Payment for any such extension must be received by LICENSORS LICENSOR within [ * ] business days following the expiration of the period during which any diligence obligation was required to be met. COMPANY shall provide reports to LICENSORS LICENSOR every [ * ] days following its NDA filing(s) concerning the status of such filing(s) until final approval thereof. Each such report shall describe the status of the COMPANY's NDA and disclose any request for additional information or data received by COMPANY from the FDA during the reporting period and COMPANY's plans for complying with such request. COMPANY shall immediately notify LICENSORS if COMPANY determines that it is unwilling to comply with any FDA requirement the failure with which to comply would result in the given Licensed Product being unapprovable by the FDA (which notice is hereinafter referred to as a "Failure of Diligence Notice"). Upon receipt of such a Failure of Diligence Notice, COMPANY shall be deemed to have failed to meet its diligence obligations, and LICENSORS may thereafter invoke any remedy provided for in this Article without any further notice to COMPANY.
(b) In the event COMPANY fails to meet any diligence requirement set forth herein in respect of the Licensed Products, LICENSORS shall have the option in their sole discretion to (i) terminate the Agreement within the entire Licensed Territory or any portion of the Licensed Territory, (ii) convert the license granted in this Agreement into a non-exclusive license within the entire Licensed Territory or any portion of the Licensed Territory, or (iii) * CONFIDENTIAL TREATMENT REQUESTED CS-92 terminate the Agreement within a portion of the Licensed Territory and convert the license granted in this Agreement into a non-exclusive license within a portion of the Licensed Territory.
(c) Upon exercise by LICENSORS of any portion of their rights under the preceding Subsection, COMPANY shall deliver to LICENSORS all data, and shall grant to LICENSORS and their sublicensees a non-exclusive, royalty free license under all intellectual property rights in COMPANY's or COMPANY's sublicensees' control and required for regulatory or commercial reasons in order to market any Licensed Product in the country or countries in which termination has occurred. COMPANY shall further provide LICENSORS, promptly upon request, copies of the IND, NDA or other documents required for regulatory approvals for Sale in the United States and any foreign countries provided that such termination has occurred with respect to such countries. COMPANY shall, further permit LICENSORS and any licensee of LICENSORS to cross-reference such filings for such indication and shall sell LICENSORS or LICENSORS' licensees any Licensed Compounds or intermediates used in the synthesis of such Licensed Compounds (and not being used by COMPANY for the synthesis of other compounds) at COMPANY's cost.
(d) Prior to exercising any rights under this Section, LICENSORS shall give COMPANY [ * ] notice and shall meet with COMPANY, at COMPANY's request and expense, during such [ * ] period, to discuss any disagreements about whether COMPANY has complied with the requirements of this Section. Upon expiration of such [ * ] period, LICENSORS shall have the right in their sole discretion to proceed with the * CONFIDENTIAL TREATMENT REQUESTED CS-92 exercise of all rights and remedies provided for herein unless the applicable diligence obligation is met during such [ * ] period.Confidential Treatment Requested
Appears in 1 contract