Obligations of Licensee. 7.1 Licensee hereby undertakes and agrees with Licensor that it will at all times during the Term observe and perform the terms and conditions set out in this Agreement and in particular shall: (a) use diligent efforts to effect introduction of the Licensed Products into the commercial market as soon as practicable, consistent with reasonable and sound business practice and judgment in order the achieve the Performance Objectives by the respective Dates of Achievement specified in Section 7.2; (b) deliver to NUS, such part of the Licensee’s annual audited financial statements which pertain to the Gross Sales of the Licensed Products and Licensed Processes and Sub-licensing Revenue, at the end of the first quarter following the end of each financial year of Licensee during the Term. For clarity, NUS is only entitled to view and review (if necessary) Licensee’s financial statements which pertain to the Gross Sales of the Licensed Products and Sub-licensing Revenue and no other financial statements of Licensee whatsoever. (c) deliver to NUS, Licensee’s annual budget for the subsequent financial year as well as a technical/development update, no later than the end of Licensee’s financial year commencing the first year from the introduction of the Licensed Products into the commercial market in the Territory or 31 December 2014 whichever is the later and thereafter based on the Licensee’s financial year. 7.2 Licensee also undertakes to meet the following Performance Objectives by the respective Dates of Achievement whether by the Licensee, the Sub-Licensees or the Licensee’s assignees: Commencement of a Phase II Clinical Trial involving Licensed Product or Process 3 years from Effective Date Commencement of a Phase III Clinical Trial involving Licensed Product or Process 5 years from Effective Date Submission for Regulatory Approval involving Licensed Product or Licensed Process 2 years from Completion of Phase III Clinical Program Market Launch of Licensed Product or Licensed Process 9 months from the date of Regulatory Approval involving Licensed Product or Licensed Process. 7.3 Within twelve (12) months the date of Market Launch of Licensed Product or Licensed Process, Licensee and Licensor shall have good faith discussions on projected sales of the Licensed Products for the next three (3) years and mutually agree on the performance objectives of Licensee. 7.4 If Licensee fails to fulfill the performance objectives mutually agreed between Licensee and Licensor pursuant to Section 7.2 above, the Parties shall have good faith discussions on the reasons for such failure to meet the mutually agreed performance objectives. If Licensee is unable to provide any valid reasons reasonably satisfactory to Licensor, Licensor shall grant to Licensee a further grace period of 9 months for each of the respective dates of achievement set out in Section 7.2 and in the event that Licensee is still unable to meet the respective dates of achievement, Licensors, at its option, have the right, by notice in writing to Licensee, to immediately: (i) terminate the exclusivity, sublicensing right and transferability of the License granted under Section 3.1 and grant licenses to other third party licensees in the Territory; or (ii) terminate this Agreement pursuant to Section 19.1(a).
Appears in 2 contracts
Samples: Exclusive License Agreement (60 Degrees Pharmaceuticals, Inc.), Exclusive License Agreement (60 Degrees Pharmaceuticals, Inc.)
Obligations of Licensee. 7.1 Licensee hereby undertakes and agrees with Licensor that it will at all times during the Term observe and perform the terms and conditions set out in this Agreement and in particular shall:
(a) use diligent efforts to effect introduction of the Licensed Products into the commercial market as soon as practicable, consistent with reasonable and sound business practice and judgment in order the achieve the Performance Objectives by the respective Dates of Achievement specified in Section 7.2;
(b) deliver to NUS, such part of the Licensee’s annual audited financial statements which pertain to the Gross Sales of the Licensed Products and Licensed Processes and Sub-licensing Revenue, at the end of the first quarter following the end of each financial year of Licensee during the Term. For clarity, NUS is only entitled to view and review (if necessary) Licensee’s financial statements which pertain to the Gross Sales of the Licensed Products and Sub-licensing Revenue and no other financial statements of Licensee whatsoever.
(c) deliver to NUS, Licensee’s annual budget for the subsequent financial year as well as a technical/development update, no later than the end of Licensee’s 's financial year commencing the first year from the introduction of the Licensed Products into the commercial market in the Territory or 31 December 2014 whichever is the later and thereafter based on the Licensee’s 's financial year.
7.2 Licensee also undertakes to meet the following Performance Objectives by the respective Dates of Achievement whether by the Licensee, the Sub-Licensees or the Licensee’s 's assignees: Commencement of a Phase II Clinical Trial involving Licensed Product or Process 3 years from Effective Date Commencement of a Phase III Clinical Trial involving Licensed Product or Process 5 years from Effective Date Submission for Regulatory Approval involving Licensed Product or Licensed Process 2 years from Completion of Phase III Clinical Program Market Launch of Licensed Product or Licensed Process 9 months from the date of Regulatory Approval involving Licensed Product or Licensed Process.
7.3 Within twelve (12) months the date of Market Launch of Licensed Product or Licensed Process, Licensee and Licensor shall have good faith discussions on projected sales of the Licensed Products for the next three (3) years and mutually agree on the performance objectives of Licensee.
7.4 If Licensee fails to fulfill the performance objectives mutually agreed between Licensee and Licensor pursuant to Section 7.2 above, the Parties shall have good faith discussions on the reasons for such failure to meet the mutually agreed performance objectives. If Licensee is unable to provide any valid reasons reasonably satisfactory to Licensor, Licensor shall grant to Licensee a further grace period of 9 months for each of the respective dates of achievement set out in Section 7.2 and in the event that Licensee is still unable to meet the respective dates of achievement, Licensors, at its option, have the right, by notice in writing to Licensee, to immediately: (i) terminate the exclusivity, sublicensing right and transferability of the License granted under Section 3.1 and grant licenses to other third party licensees in the Territory; or (ii) terminate this Agreement pursuant to Section 19.1(a).
Appears in 2 contracts
Samples: Exclusive License Agreement (60 Degrees Pharmaceuticals, Inc.), Exclusive License Agreement (60 Degrees Pharmaceuticals, Inc.)
Obligations of Licensee. 7.1 3.1 Licensee hereby undertakes and agrees shall use the Licensed Trademark in connection with Licensor that it will at all times during the Term observe and perform the terms and conditions set out in this Agreement and in particular shall:
(a) use diligent efforts to effect introduction sale of the Licensed Products into Product. Such use shall comply with the commercial market as soon as practicablestandards, consistent with reasonable specifications, instructions and sound business practice and judgment directions approved by Licensor in order the achieve the Performance Objectives by the respective Dates of Achievement specified in Section 7.2;
(b) deliver to NUS, such part of the Licensee’s annual audited financial statements which pertain to the Gross Sales of the Licensed Products and Licensed Processes and Sub-licensing Revenue, at the end of the first quarter following the end of each financial year of Licensee during the Term. For clarity, NUS is only entitled to view and review (if necessary) Licensee’s financial statements which pertain to the Gross Sales of the Licensed Products and Sub-licensing Revenue and no other financial statements of Licensee whatsoeverwriting.
(c) deliver to NUS, Licensee’s annual budget for the subsequent financial year as well as a technical/development update, no later than the end of Licensee’s financial year commencing the first year from the introduction of the Licensed Products into the commercial market in the Territory or 31 December 2014 whichever is the later and thereafter based on the Licensee’s financial year.
7.2 Licensee also undertakes to meet the following Performance Objectives by the respective Dates of Achievement whether by the Licensee, the Sub-Licensees or the Licensee’s assignees: Commencement of a Phase II Clinical Trial involving Licensed Product or Process 3 years from Effective Date Commencement of a Phase III Clinical Trial involving Licensed Product or Process 5 years from Effective Date Submission for Regulatory Approval involving Licensed Product or Licensed Process 2 years from Completion of Phase III Clinical Program Market Launch of Licensed Product or Licensed Process 9 months from the date of Regulatory Approval involving Licensed Product or Licensed Process.
7.3 Within twelve (12) months the date of Market Launch of Licensed Product or Licensed Process, Licensee and Licensor shall have good faith discussions on projected sales of the Licensed Products for the next three (3) years and mutually agree on the performance objectives of Licensee.
7.4 If Licensee fails to fulfill the performance objectives mutually agreed between Licensee and Licensor pursuant to Section 7.2 above, the Parties shall have good faith discussions on the reasons for such failure to meet the mutually agreed performance objectives. If Licensee is unable to provide any valid reasons reasonably satisfactory to Licensor, Licensor shall grant to Licensee a further grace period of 9 months for each of the respective dates of achievement set out in Section 7.2 and in 3.2 In the event that Licensee is still unable wants to meet change the respective dates standards, specifications, instructions and directions approved by Licensor, Licensee shall not implement any such change before the expiration of achievement, Licensors, at its option, have forty-five (45) days from the right, by date Licensee gives written notice in writing to Licensee, to immediately: (i) terminate the exclusivity, sublicensing right and transferability Licensor of the License granted desired change. In the absence of formal written refusal notified by Licensor to Licensee within such forty-five (45) day period, Licensor will be considered as having authorized such changes. In the event of formal written refusal, and if Licensee still wishes to implement such change in the Product, this Agreement may be terminated by Licensor subject to a notice period of three months, during which period such change shall be withheld.
3.3 Licensee undertakes to comply with all laws pertaining to trademarks in force at any time in the Territory including, but not limited to, compliance with marking requirements and shall indicate on all labeling, packaging or printed material that the Licensed Trademark is registered, is owned by Licensor and is licensed from Licensor.
3.4 Licensee will permit Licensor or one or more duly authorized representatives or agents of Licensor to inspect, examine and test the Product, on the premises of Licensee at all reasonable times, and to inspect the offices, CONFIDENTIAL INFORMATION OMITTED AND FILED SEPARATELY WITH SECURITIES AND EXCHANGE COMMISSION ASTERISKS DENOTE SUCH OMISSION plants, equipment, facilities, and materials of Licensee which relate to the Licensee's use of the Licensed Trademark. Licensee shall, upon request of Licensor, submit without cost to Licensor or its duly authorized representative or agent samples of the Product which it sells or intends to sell under Section 3.1 the Licensed Trademark for the purpose of ascertaining compliance with the provisions of this Agreement.
3.5 Licensee agrees that the Product shall be of a very high standard and grant licenses quality so as to other third party licensees protect and enhance the prestige of the Licensed Trademark and the goodwill pertaining thereto. Licensor shall advise Licensee of each and every discrepancy in such very high degree of quality or in the adherence to the standards, specifications, instructions and directions approved by Licensor, whereupon Licensee shall promptly arrange to the satisfaction of Licensor for correction of each and every such discrepancy.
3.6 Consistent with the terms hereof, Licensee agrees to use commercially reasonable efforts to promote a very high level of good reputation of the Licensed Trademark in connection with the manufacture, promotion and sale of the Product.
3.7 Licensee shall also use commercially reasonable efforts to obtain FDA approval for the Product and to commercialize the Product in the Territory; or (ii) terminate . Licensee shall provide BMS with quarterly written updates on the progress Licensee is making with respect to obtaining FDA approval for the Product *****.
3.8 Failure to abide by the quality control provisions in this Agreement pursuant to Section 19.1(a)constitutes a material breach of this Agreement.
Appears in 1 contract
Obligations of Licensee. 7.1 3.1 Licensee hereby undertakes and agrees shall use the Licensed Trademark in connection with Licensor that it will at all times during the Term observe and perform the terms and conditions set out in this Agreement and in particular shall:
(a) use diligent efforts to effect introduction sale of the Licensed Products into Product. Such use shall comply with the commercial market as soon as practicablestandards, consistent with reasonable specifications, instructions and sound business practice and judgment directions approved by Licensor in order the achieve the Performance Objectives by the respective Dates of Achievement specified in Section 7.2;
(b) deliver to NUS, such part of the Licensee’s annual audited financial statements which pertain to the Gross Sales of the Licensed Products and Licensed Processes and Sub-licensing Revenue, at the end of the first quarter following the end of each financial year of Licensee during the Term. For clarity, NUS is only entitled to view and review (if necessary) Licensee’s financial statements which pertain to the Gross Sales of the Licensed Products and Sub-licensing Revenue and no other financial statements of Licensee whatsoeverwriting.
(c) deliver to NUS, Licensee’s annual budget for the subsequent financial year as well as a technical/development update, no later than the end of Licensee’s financial year commencing the first year from the introduction of the Licensed Products into the commercial market in the Territory or 31 December 2014 whichever is the later and thereafter based on the Licensee’s financial year.
7.2 Licensee also undertakes to meet the following Performance Objectives by the respective Dates of Achievement whether by the Licensee, the Sub-Licensees or the Licensee’s assignees: Commencement of a Phase II Clinical Trial involving Licensed Product or Process 3 years from Effective Date Commencement of a Phase III Clinical Trial involving Licensed Product or Process 5 years from Effective Date Submission for Regulatory Approval involving Licensed Product or Licensed Process 2 years from Completion of Phase III Clinical Program Market Launch of Licensed Product or Licensed Process 9 months from the date of Regulatory Approval involving Licensed Product or Licensed Process.
7.3 Within twelve (12) months the date of Market Launch of Licensed Product or Licensed Process, Licensee and Licensor shall have good faith discussions on projected sales of the Licensed Products for the next three (3) years and mutually agree on the performance objectives of Licensee.
7.4 If Licensee fails to fulfill the performance objectives mutually agreed between Licensee and Licensor pursuant to Section 7.2 above, the Parties shall have good faith discussions on the reasons for such failure to meet the mutually agreed performance objectives. If Licensee is unable to provide any valid reasons reasonably satisfactory to Licensor, Licensor shall grant to Licensee a further grace period of 9 months for each of the respective dates of achievement set out in Section 7.2 and in 3.2 In the event that Licensee is still unable wants to meet change the respective dates standards, specifications, instructions and directions approved by Licensor, Licensee shall not implement any such change before the expiration of achievement, Licensors, at its option, have forty-five (45) days from the right, by date Licensee gives written notice in writing to Licensee, to immediately: (i) terminate the exclusivity, sublicensing right and transferability Licensor of the License granted desired change. In the absence of formal written refusal notified by Licensor to Licensee within such forty-five (45) day period, Licensor will be considered as having authorized such changes. In the event of formal written refusal, and if Licensee still wishes to implement such change in the Product, this Agreement may be terminated by Licensor subject to a notice period of three months, during which period such change shall be withheld.
3.3 Licensee undertakes to comply with all laws pertaining to trademarks in force at any time in the Territory including, but not limited to, compliance with marking requirements and shall indicate on all labeling, packaging or printed material that the Licensed Trademark is registered, is owned by Licensor and is licensed from Licensor.
3.4 Licensee will permit Licensor or one or more duly authorized representatives or agents of Licensor to inspect, examine and test the Product, on the premises of Licensee at all reasonable times, and to inspect the offices, plants, equipment, facilities, and materials of Licensee which relate to the Licensee's use of the Licensed Trademark. Licensee shall, upon request of Licensor, submit without cost to Licensor or its duly authorized representative or agent samples of the Product which it sells or intends to sell under Section 3.1 the Licensed Trademark for the purpose of ascertaining compliance with the provisions of this Agreement.
3.5 Licensee agrees that the Product shall be of a very high standard and grant licenses quality so as to other third party licensees protect and enhance the prestige of the Licensed Trademark and the goodwill pertaining thereto. Licensor shall advise Licensee of each and every discrepancy in such very high degree of quality or in the adherence to the standards, specifications, instructions and directions approved by Licensor, whereupon Licensee shall promptly arrange to the satisfaction of Licensor for correction of each and every such discrepancy.
3.6 Consistent with the terms hereof, Licensee agrees to use commercially reasonable efforts to promote a very high level of good reputation of the Licensed Trademark in connection with the manufacture, promotion and sale of the Product.
3.7 Licensee shall also use commercially reasonable efforts to obtain FDA approval for the Product and to commercialize the Product in the Territory; or (ii) terminate . Licensee shall provide BMS with quarterly written updates on the progress Licensee is making with respect to obtaining FDA approval for the Product *****.
3.8 Failure to abide by the quality control provisions in this Agreement pursuant to Section 19.1(a)constitutes a material breach of this Agreement.
Appears in 1 contract
Obligations of Licensee. 7.1 3.1 Licensee hereby undertakes and agrees shall use the Licensed Trademark in connection with Licensor that it will at all times during the Term observe and perform the terms and conditions set out in this Agreement and in particular shall:
(a) use diligent efforts to effect introduction sale of the Licensed Products into Product. Such use shall comply with the commercial market as soon as practicablestandards, consistent with reasonable specifications, instructions and sound business practice and judgment directions approved by Licensor in order the achieve the Performance Objectives by the respective Dates of Achievement specified in Section 7.2;
(b) deliver to NUS, such part of the Licensee’s annual audited financial statements which pertain to the Gross Sales of the Licensed Products and Licensed Processes and Sub-licensing Revenue, at the end of the first quarter following the end of each financial year of Licensee during the Term. For clarity, NUS is only entitled to view and review (if necessary) Licensee’s financial statements which pertain to the Gross Sales of the Licensed Products and Sub-licensing Revenue and no other financial statements of Licensee whatsoeverwriting.
(c) deliver to NUS, Licensee’s annual budget for the subsequent financial year as well as a technical/development update, no later than the end of Licensee’s financial year commencing the first year from the introduction of the Licensed Products into the commercial market in the Territory or 31 December 2014 whichever is the later and thereafter based on the Licensee’s financial year.
7.2 Licensee also undertakes to meet the following Performance Objectives by the respective Dates of Achievement whether by the Licensee, the Sub-Licensees or the Licensee’s assignees: Commencement of a Phase II Clinical Trial involving Licensed Product or Process 3 years from Effective Date Commencement of a Phase III Clinical Trial involving Licensed Product or Process 5 years from Effective Date Submission for Regulatory Approval involving Licensed Product or Licensed Process 2 years from Completion of Phase III Clinical Program Market Launch of Licensed Product or Licensed Process 9 months from the date of Regulatory Approval involving Licensed Product or Licensed Process.
7.3 Within twelve (12) months the date of Market Launch of Licensed Product or Licensed Process, Licensee and Licensor shall have good faith discussions on projected sales of the Licensed Products for the next three (3) years and mutually agree on the performance objectives of Licensee.
7.4 If Licensee fails to fulfill the performance objectives mutually agreed between Licensee and Licensor pursuant to Section 7.2 above, the Parties shall have good faith discussions on the reasons for such failure to meet the mutually agreed performance objectives. If Licensee is unable to provide any valid reasons reasonably satisfactory to Licensor, Licensor shall grant to Licensee a further grace period of 9 months for each of the respective dates of achievement set out in Section 7.2 and in 3.2 In the event that Licensee is still unable wants to meet change the respective dates standards, specifications, instructions and directions approved by Licensor, Licensee shall not implement any such change before the expiration of achievement, Licensors, at its option, have forty-five (45) days from the right, by date Licensee gives written notice in writing to Licensee, to immediately: (i) terminate the exclusivity, sublicensing right and transferability Licensor of the License granted desired change. In the absence of formal written refusal notified by Licensor to Licensee within such forty-five (45) day period, Licensor will be considered as having authorized such changes. In the event of formal written refusal, and if Licensee still wishes to implement such change in the Product, this Agreement may be terminated by Licensor subject to a notice period of three months, during which period such change shall be withheld.
3.3 Licensee undertakes to comply with all laws pertaining to trademarks in force at any time in the Territory including, but not limited to, compliance with marking requirements and shall indicate on all labeling, packaging or printed material that the Licensed Trademark is registered, is owned by Licensor and is licensed from Licensor.
3.4 Licensee will permit Licensor or one or more duly authorized representatives or agents of Licensor to inspect, examine and test the Product, CONFIDENTIAL INFORMATION OMITTED AND FILED SEPARATELY WITH SECURITIES AND EXCHANGE COMMISSION ASTERISKS DENOTE SUCH OMISSION on the premises of Licensee at all reasonable times, and to inspect the offices, plants, equipment, facilities, and materials of Licensee which relate to the Licensee's use of the Licensed Trademark. Licensee shall, upon request of Licensor, submit without cost to Licensor or its duly authorized representative or agent samples of the Product which it sells or intends to sell under Section 3.1 the Licensed Trademark for the purpose of ascertaining compliance with the provisions of this Agreement.
3.5 Licensee agrees that the Product shall be of a very high standard and grant licenses quality so as to other third party licensees protect and enhance the prestige of the Licensed Trademark and the goodwill pertaining thereto. Licensor shall advise Licensee of each and every discrepancy in such very high degree of quality or in the adherence to the standards, specifications, instructions and directions approved by Licensor, whereupon Licensee shall promptly arrange to the satisfaction of Licensor for correction of each and every such discrepancy.
3.6 Consistent with the terms hereof, Licensee agrees to use commercially reasonable efforts to promote a very high level of good reputation of the Licensed Trademark in connection with the manufacture, promotion and sale of the Product.
3.7 Licensee shall also use commercially reasonable efforts to obtain FDA approval for the Product and to commercialize the Product in the Territory; or (ii) terminate . Licensee shall provide BMS with quarterly written updates on the progress Licensee is making with respect to obtaining FDA approval for the Product *****.
3.8 Failure to abide by the quality control provisions in this Agreement pursuant to Section 19.1(a)constitutes a material breach of this Agreement.
Appears in 1 contract