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.
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.
Appears in 1 contract
Samples: 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 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.* Confidential Treatment Requested
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 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
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