Development. 3.1.1 Licensee agrees to and warrants that: it has, or will obtain, the expertise necessary to independently evaluate the inventions of the Licensed Patents; it will establish and actively and diligently pursue the Development Plan (see Appendix A) to the end that the inventions of the Licensed Patents will be utilized to provide Licensed Products and/or Licensed Processes for sale in the retail market within the Licensed Field; and until the date of first commercial sale of Licensed Products, it will supply UFRF with a written Development Report annually fifteen (15) days after the end of the calendar year (see Appendix B). All development activities and strategies and all aspects of product design and [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. decisions to market and the like are entirely at the discretion of Licensee, and Licensee shall rely entirely on its own expertise with respect thereto. UFRF’s review of Licensee’s Development Plan is solely to verify the existence of Licensee’s commitment to development activity and to ensure compliance with Licensee’s obligations to commercialize the inventions of the Licensed Patents, as set forth above, other than those elements of the Development Plan as designated as Due Diligence milestones in 3.1.2 below. 3.1.2 Licensee agrees that the first commercial sale of products to the retail customer shall occur on or before January 1, 2011 or UFRF shall have the right to terminate the Agreement pursuant to Section 9.3 hereto. In addition, Licensee agrees to the following due diligence elements which if not accomplished by the following dates, then UFRF shall have the right to terminate the Agreement pursuant to Section 9.3: (1) Complete business plan and STTR grant application 4th Q 2004 (2) Complete proof-of-concept 4th Q 2005 (3) Secure design/mfg relationship with OEM manufacturer 2nd Q 2006 (4) Potential need for VC round 2008 (5) Complete working commercial prototype 2010 (6) Hire industry CEO 2010 (7) FDA 510k approval 2011 (8) Market launch of first generation Device 2011 (9) Market launch of second generation Device 2013 If Licensee fails to actively pursue the Development Plan with respect to a certain field(s) of use and UFRF has received notice that a third party wishes to negotiate a license for such field(s) of use, UFRF may terminate this License with respect to such field(s) of use upon sixty (60) days written notice to Licensee and pursue negotiations with the third party. Licensee shall have the right to come into compliance within 90 days. During the notice period, Licensee may provide UFRF with a revised Development Plan with respect to the field(s) of use in question. UFRF may consider the revised Development Plan and determine, in UFRF’s sole discretion, whether the revised Development Plan will be accepted or whether the License will terminate with respect to such field(s) of use upon expiration of the notice period. [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
Appears in 6 contracts
Sources: Standard Exclusive License Agreement (ViewRay, Inc.), Standard Exclusive License Agreement (ViewRay, Inc.), Standard Exclusive License Agreement (ViewRay, Inc.)
Development. 3.1.1 Licensee agrees to and warrants that: it has, or will obtain, the expertise necessary to independently evaluate the inventions of the Licensed Patents; it will establish and actively and diligently [***] pursue the Development Plan (see Appendix A) to the end that the inventions of the Licensed Patents will be utilized to provide Licensed Products and/or Licensed Processes for sale in the retail market within the Licensed Field; and until the date of first commercial sale of Licensed Products, it will supply UFRF with a written Development Report annually fifteen (15) days after the end of the calendar year (see Appendix B). All development activities and strategies and all aspects of product design and [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. decisions to market and the like are entirely at the discretion of Licensee, and Licensee shall rely entirely on its own expertise with respect thereto. UFRF’s review of Licensee’s Development Plan is solely to verify [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. the existence of Licensee’s commitment to development activity and to ensure compliance with Licensee’s obligations to commercialize the inventions of the Licensed Patents, as set forth above, other than those elements of the Development Plan as designated as Due Diligence milestones in 3.1.2 below.
3.1.2 Licensee agrees that the first commercial sale of products to the retail customer shall occur on or before January 1, 2011 or UFRF shall have the right to terminate the Agreement pursuant to Section 9.3 hereto. In addition, Licensee agrees to the following due diligence elements which if not accomplished by the following dates, then UFRF shall have the right to terminate the Agreement pursuant to Section 9.3:
(1) Complete business plan and STTR grant application 4th Q 2004
(2) Complete proof-of-concept 4th Q 2005
(3) Secure design/mfg relationship with OEM manufacturer 2nd Q 2006
(4) Potential need for VC round 2008
(5) Complete working commercial prototype 2010
(6) Hire industry CEO 2010
(7) FDA 510k approval 2011
(8) Market launch of first generation Device 2011
(9) Market launch of second generation Device 2013 If Licensee fails to actively pursue the Development Plan with respect to a certain field(s) of use and UFRF has received notice that a third party wishes to negotiate a license for such field(s) of use, UFRF may terminate this License with respect to such field(s) of use upon sixty (60) days written notice to Licensee and pursue negotiations with the third party. Licensee shall have the right to come into compliance within 90 days. During the notice period, Licensee may provide UFRF with a revised Development Plan with respect to the field(s) of use in question. UFRF may consider the revised Development Plan and determine, in UFRF’s sole discretion, whether the revised Development Plan will be accepted or whether the License will terminate with respect to such field(s) of use upon expiration of the notice period. [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
Appears in 2 contracts
Sources: Standard Exclusive License Agreement, Standard Exclusive License Agreement (Viewray Inc)
Development. 3.1.1 Licensee agrees to and warrants that: :
(a) it has, or will obtain, the expertise necessary to independently evaluate the inventions of the Licensed Patents; Patents and Know-How;
(b) it will establish and actively and diligently pursue the Development Plan Plan, (see Appendix A) to the end that the inventions of the Licensed Patents will be utilized to provide Licensed Products and/or Licensed Processes for sale in the retail market within the Licensed Field; ;
(c) it will diligently develop markets for Licensed Products and Licensed Processes;
(d) and, until the date of first commercial sale First Commercial Sale of Licensed ProductsProducts or Licensed Processes, it will supply UFRF Licensor with a written Development Report annually within fifteen (15) days after the end of the calendar year (see Appendix BB ). All development activities and strategies and all aspects of product design and [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. decisions to market and the like are entirely at the discretion of Licensee, and Licensee shall rely entirely on its own expertise with respect thereto. UFRF’s review of Licensee’s Development Plan is solely to verify the existence of Licensee’s commitment to development activity and to ensure compliance with Licensee’s obligations to commercialize the inventions of the Licensed Patents, as set forth above, other than those elements of the Development Plan as designated as Due Diligence milestones in 3.1.2 below.
3.1.2 Licensee agrees that the first commercial sale First Commercial Sale of products to the retail customer shall occur on or before January July 1, 2011 2027 or UFRF Licensor shall have the right to terminate the this Agreement pursuant to Section 9.3 hereto. In addition, Licensee agrees to will meet the following due diligence elements which if not accomplished by the following dates, then UFRF milestones shown in Appendix D or Licensor shall have the right to terminate the this Agreement pursuant to Section 9.3:. Licensee will notify Licensor in writing as each milestone is met.
(1) Complete business plan and STTR grant application 4th Q 2004
(2) Complete proof-of-concept 4th Q 2005
(3) Secure design/mfg relationship with OEM manufacturer 2nd Q 2006
(4) Potential need for VC round 2008
(5) Complete working commercial prototype 2010
(6) Hire industry CEO 2010
(7) FDA 510k approval 2011
(8) Market launch of first generation Device 2011
(9) Market launch of second generation Device 2013 If 3.1.3 Upon written request by Licensee fails to actively pursue the Development Plan with respect to a certain field(s) of use and UFRF has received notice that a third party wishes to negotiate a license for extensions of any milestones or due dates set forth in Appendix D, such field(s) of use, UFRF may terminate this License with respect request to such field(s) of use upon sixty be received by Licensor no less than ninety (6090) days written notice prior to Licensee any of the due dates subject of such request, set forth in this Section 3.1.3, such request fully describing Licensee’s diligent efforts to achieve the milestone required to be met by such due date, Licensor shall consider in good faith such requests. Upon granting such request, Licensor and pursue negotiations with the third party. Licensee shall have the right to come into compliance within 90 daysnegotiate such extensions in good faith.
3.1.4 University’s policies may require approval of clinical trials involving technology invented by Licensor. During the notice periodAccordingly, Licensee may will notify Licensor prior to commencing any clinical trials at the University’s facility or any affiliated medical facilities.
3.1.5 Every year Licensor is required to report on statistics that are relevant to growth of businesses in Florida. On January 31 and July 31 of each year, Licensee shall provide UFRF with to Licensor a revised Development Plan with respect report that includes: the current number of employees in Florida, the total number of employees, information about whether Licensee has gone public or been acquired, detail on the amount and sources of funding, any new products that have been introduced to the field(s) market, the number of use in questionemployees who are University graduates, and the number of University interns for the period since the last report was received. UFRF may consider the revised Development Plan and determine, in UFRF’s sole discretion, whether the revised Development Plan This specific information will be accepted or whether held in confidence and provided in the License aggregate. No information obtained under this Section 3.1.5 will terminate be identified as being connected with respect to such field(s) of use upon expiration Licensee absent agreement of the notice period. [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portionsLicensee.
Appears in 2 contracts
Sources: Standard Exclusive License Agreement (Alzamend Neuro, Inc.), Standard Exclusive License Agreement (Alzamend Neuro, Inc.)
Development. 3.1.1 Licensee agrees to and warrants that: :
(a) it has, or will obtain, the expertise necessary to independently evaluate the inventions of the Licensed Patents; ;
(b) it will establish and actively and diligently diligent!), pursue the Development Plan (see Appendix AA ) to the end that the inventions of the Licensed Patents will be utilized to provide Licensed Products and/or Licensed Processes for sale in the retail market within the Licensed Field; ;
(c) it will diligently develop markets for Licensed Products and Licensed Processes;
(d) and, until the date of first commercial sale of Licensed ProductsProducts or Licensed Processes, it will supply UFRF with a written Development Report annually fifteen (15) days after the end of the calendar year (see Appendix BB ). All development activities and strategies and all aspects of product design and [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. decisions to market and the like are entirely at the discretion of Licensee, and Licensee shall rely entirely on its own expertise with respect thereto. UFRF’s review of Licensee’s Development Plan is solely to verify the existence of Licensee’s commitment to development activity and to ensure compliance with Licensee’s obligations to commercialize the inventions of the Licensed Patents, as set forth above, other than those elements of the Development Plan as designated as Due Diligence milestones in 3.1.2 below.
3.1.2 Licensee agrees that the first commercial sale of one or more products to the retail customer shall occur on or before January August 1, 2011 2010 or UFRF shall have the right to terminate the Agreement pursuant to Section 9.3 9.4 hereto. In addition, Licensee agrees to will meet the following due diligence elements which if not accomplished by the following dates, then milestones shown in Appendix D or UFRF shall have the right to terminate the Agreement pursuant to Section 9.3:
(1) Complete business plan and STTR grant application 4th Q 2004
(2) Complete proof-of-concept 4th Q 2005
(3) Secure design/mfg relationship with OEM manufacturer 2nd Q 2006
(4) Potential need for VC round 2008
(5) Complete working commercial prototype 2010
(6) Hire industry CEO 2010
(7) FDA 510k approval 2011
(8) Market launch of first generation Device 2011
(9) Market launch of second generation Device 2013 If Licensee fails to actively pursue the Development Plan with respect to a certain field(s) of use and UFRF has received notice that a third party wishes to negotiate a license for such field(s) of use, UFRF may terminate this License with respect to such field(s) of use upon sixty (60) days written notice to Licensee and pursue negotiations with the third party9.4. Licensee shall will notify UFRF in writing as each milestone is met
3.1.3 Licensee agrees that three years after the Effective Date of this Agreement the Licensee would have the right to come into compliance within 90 days. During the notice period, Licensee may provide UFRF with a revised Development Plan with respect to the field(s) of use in question. UFRF may consider the revised Development Plan and determine, in UFRF’s sole discretion, whether the revised Development Plan will be accepted or whether the License will terminate with respect to such field(s) of use upon expiration achieved one of the notice periodfollowing milestones: a) Completion of at least one sublicense for rights under the Licensed Patents or Licensed Process or b) Production of 10 Kilogram sample quantities of the Licensed Products by the Licensee. If neither of these milestones is met by the License, then the Licensee shall pay UFRF $[...***...] Certain information for a one time, non-refundable, 2-year extension to meet either milestone. Failure to meet either milestone after the 2-year extension is a material breach of this Agreement and grounds for termination pursuant to Section 9.3 hereto.
3.1.4 Upon written request by Licensee to negotiate extensions of any Milestones Due Dates set forth in Appendix D, such request to be received by UFRF no less than ninety (90) days prior to any of the Due Dates subject of such request, set forth in this document has been omitted Section 3.1.3, such request fully describing Licensees Commercially Reasonable Efforts to achieve the Milestone required to be met by such Due Date, UFRF shall consider in good faith such requests. Upon granting such request, UFRF and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.Licensee shall negotiate such extensions in good faith
Appears in 2 contracts
Sources: Standard Exclusive License Agreement (Myriant Corp), Standard Exclusive License Agreement (Myriant Corp)
Development. 3.1.1 Licensee agrees to and warrants that: :
(a) it has, or will obtain, the expertise necessary to independently evaluate the inventions of the Licensed Patents; ;
(b) it will establish and actively and diligently pursue the Development Plan (see Appendix AA ) to the end that the inventions of the Licensed Patents will be utilized to provide Licensed Products and/or Licensed Processes for sale in the retail market within the Licensed Field; ;
(c) it will diligently develop markets for Licensed Products and Licensed Processes;
(d) and, until the date of first commercial sale of Licensed ProductsProducts or Licensed Processes, it will supply UFRF with a written Development Report annually fifteen (15) days after the end of the calendar year (see Appendix BB ). All development activities and strategies and all aspects of product design and [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. decisions to market and the like are entirely at the discretion of Licensee, and Licensee shall rely entirely on its own expertise with respect thereto. UFRF’s review of Licensee’s Development Plan is solely to verify the existence of Licensee’s commitment to development activity and to ensure compliance with Licensee’s obligations to commercialize the inventions of the Licensed Patents, as set forth above, other than those elements of the Development Plan as designated as Due Diligence milestones in 3.1.2 below.
3.1.2 Licensee agrees that the first commercial sale of one or more products to the retail customer shall occur on or before January August 1, 2011 2010 or UFRF shall have the right to terminate the Agreement pursuant to Section 9.3 9.4 hereto. In addition, Licensee agrees to will meet the following due diligence elements which if not accomplished by the following dates, then milestones shown in Appendix D or UFRF shall have the right to terminate the Agreement pursuant to Section 9.3:
(1) Complete business plan and STTR grant application 4th Q 2004
(2) Complete proof-of-concept 4th Q 2005
(3) Secure design/mfg relationship with OEM manufacturer 2nd Q 2006
(4) Potential need for VC round 2008
(5) Complete working commercial prototype 2010
(6) Hire industry CEO 2010
(7) FDA 510k approval 2011
(8) Market launch of first generation Device 2011
(9) Market launch of second generation Device 2013 If Licensee fails to actively pursue the Development Plan with respect to a certain field(s) of use and UFRF has received notice that a third party wishes to negotiate a license for such field(s) of use, UFRF may terminate this License with respect to such field(s) of use upon sixty (60) days written notice to Licensee and pursue negotiations with the third party9.4. Licensee shall will notify UFRF in writing as each milestone is met
3.1.3 Licensee agrees that three years after the Effective Date of this Agreement the Licensee would have the right to come into compliance within 90 days. During the notice period, Licensee may provide UFRF with a revised Development Plan with respect to the field(s) of use in question. UFRF may consider the revised Development Plan and determine, in UFRF’s sole discretion, whether the revised Development Plan will be accepted or whether the License will terminate with respect to such field(s) of use upon expiration achieved one of the notice periodfollowing milestones: a) Completion of at least one sublicense for rights under the Licensed Patents or Licensed Process or b) Production of 10 Kilogram sample quantities of the Licensed Products by the Licensee. If neither of these milestones is met by the License, then the Licensee shall pay UFRF $[...***...] Certain information for a one time, non-refundable, 2-year extension to meet either milestone. Failure to meet either milestone after the 2-year extension is a material breach of this Agreement and grounds for termination pursuant to Section 9.3 hereto.
3.1.4 Upon written request by Licensee to negotiate extensions of any Milestones Due Dates set forth in Appendix D, such request to be received by UFRF no less than ninety (90) days prior to any of the Due Dates subject of such request, set forth in this document has been omitted Section 3.1.3, such request fully describing Licensees Commercially Reasonable Efforts to achieve the Milestone required to be met by such Due Date. UFRF shall consider in good faith such requests. Upon granting such request, UFRF and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.Licensee shall negotiate such extensions in good faith
Appears in 2 contracts
Sources: Standard Exclusive License Agreement (Myriant Corp), Standard Exclusive License Agreement (Myriant Corp)
Development. 3.1.1 Licensee agrees to and warrants that: :
(a) it has, or will obtain, the expertise necessary to independently evaluate the inventions of the Licensed Patents; ;
(b) it will establish and actively and diligently pursue the Development Plan (see Appendix AB) to the end that the inventions of the Licensed Patents will be utilized to provide Licensed Products and/or Licensed Processes for sale in the retail market within the Licensed Field;
(c) it will diligently develop markets for Licensed Products and Licensed Processes; and and
(d) until the date of first commercial sale of Licensed ProductsProducts or Licensed Processes, it will supply UFRF FSURF with a written Development Report annually fifteen (15) days after the end of the calendar year (see Appendix BC). All development activities and strategies and all aspects of product design and [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. decisions to market and the like are entirely at the discretion of Licensee, and Licensee shall rely entirely on its own expertise with respect thereto. UFRF’s review of Licensee’s Development Plan is solely to verify the existence of Licensee’s commitment to development activity and to ensure compliance with Licensee’s obligations to commercialize the inventions of the Licensed Patents, as set forth above, other than those elements of the Development Plan as designated as Due Diligence milestones in 3.1.2 below.
3.1.2 Licensee agrees that the first commercial sale of products to the retail customer shall occur on or before January 1, 2011 2023 or UFRF FSURF shall have the right to terminate the Agreement pursuant to Section 9.3 hereto. In addition, Licensee agrees to pay the following product development milestone payments listed in Section 4.3.3 and to complete the due diligence elements which if not accomplished by the following dates, then UFRF activities listed in Appendix E or FSURF shall have the right to terminate the Agreement pursuant to Section 9.3:. Licensee will notify FSURF in writing as each milestone or due diligence activity is met.
(1) Complete business plan and STTR grant application 4th Q 2004
(2) Complete proof-of-concept 4th Q 2005
(3) Secure design/mfg relationship with OEM manufacturer 2nd Q 2006
(4) Potential need for VC round 2008
(5) Complete working commercial prototype 2010
(6) Hire industry CEO 2010
(7) FDA 510k approval 2011
(8) Market launch of first generation Device 2011
(9) Market launch of second generation Device 2013 If 3.1.3 Licensee fails to actively pursue the Development Plan with respect to may issue a certain field(s) of use and UFRF has received notice that a third party wishes written request to negotiate a license extensions of individual milestones listed in Section 4.3.3 or due dates for individual due diligence activities listed in Appendix E. Provided that such field(s) of use, UFRF may terminate this License with respect to such field(s) of use upon sixty requests are received by FSURF no less than ninety (6090) days written notice prior to Licensee the original due date in the case of milestone payments, or no less than forty five (45) days prior to the original due date in the case of due diligence activities, and pursue negotiations with that each request describes fully Licensee’s diligent efforts to achieve the third partymilestones or complete the due diligence activities, FSURF shall consider in good faith such requests. Upon granting each such request, FSURF and Licensee shall have negotiate in good faith the right length of the extension. FSURF shall not unreasonably withhold requests to come into compliance within 90 daysnegotiate extensions.
3.1.4 Florida State University policies may require approval of clinical trials involving technology invented at the University. During the notice periodAccordingly, Licensee may provide UFRF with a revised Development Plan with respect will notify FSURF prior to the field(s) of use in question. UFRF may consider the revised Development Plan and determine, in UFRF’s sole discretion, whether the revised Development Plan will be accepted commencing any clinical trials at Florida State University or whether the License will terminate with respect to such field(s) of use upon expiration of the notice period. [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portionsits affiliated medical facilities.
Appears in 2 contracts
Sources: Standard Exclusive License Agreement (Spotlight Innovation Inc.), Standard Exclusive License Agreement (Spotlight Innovation Inc.)
Development. 3.1.1 Licensee agrees to and warrants that: :
(a) it has, or will obtain, the expertise necessary to independently evaluate the inventions of the Licensed PatentsPatents and Know-How; and
(b) it will establish and actively and diligently pursue the Development Plan (Plan, see Appendix A) to the end that the inventions of the Licensed Patents will be utilized to provide Licensed Products and/or Licensed Processes for sale in the retail market within the Licensed Field; and
(c) it will diligently develop markets for Licensed Products and Licensed Processes;
(d) and, until the date of first commercial sale of Licensed ProductsProducts or Licensed Processes, it will supply UFRF Licensor with a written Development Report annually fifteen (15) days after the end of the calendar year (see Appendix B). All development activities and strategies and all aspects of product design and [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. decisions to market and the like are entirely at the discretion of Licensee, and Licensee shall rely entirely on its own expertise with respect thereto. UFRF’s review of Licensee’s Development Plan is solely to verify the existence of Licensee’s commitment to development activity and to ensure compliance with Licensee’s obligations to commercialize the inventions of the Licensed Patents, as set forth above, other than those elements of the Development Plan as designated as Due Diligence milestones in 3.1.2 below.
3.1.2 Licensee agrees that the first commercial sale of products to the retail customer shall occur on or before January July 1, 2011 2027 or UFRF Licensor shall have the right to terminate the this Agreement pursuant to Section 9.3 hereto. In addition, Licensee agrees to will meet the following due diligence elements which if not accomplished by the following dates, then UFRF milestones shown in Appendix D or Licensor shall have the right to terminate the this Agreement pursuant to Section 9.3:. Licensee will notify Licensor in writing as each milestone is met.
(1) Complete business plan and STTR grant application 4th Q 2004
(2) Complete proof-of-concept 4th Q 2005
(3) Secure design/mfg relationship with OEM manufacturer 2nd Q 2006
(4) Potential need for VC round 2008
(5) Complete working commercial prototype 2010
(6) Hire industry CEO 2010
(7) FDA 510k approval 2011
(8) Market launch of first generation Device 2011
(9) Market launch of second generation Device 2013 If 3.1.3 Upon written request by Licensee fails to actively pursue the Development Plan with respect to a certain field(s) of use and UFRF has received notice that a third party wishes to negotiate a license for extensions of any milestones or due dates set forth in Appendix D, such field(s) of use, UFRF may terminate this License with respect request to such field(s) of use upon sixty be received by Licensor no less than ninety (6090) days written notice prior to any of the due dates subject of such request, set forth in this Section 3.1.3, such request fully describing Licensee’s diligent efforts to achieve the milestone required to be met by such due date, Licensor shall consider in good faith such requests. Upon granting such request, Licensor and Licensee shall negotiate such extensions in good faith.
3.1.4 Licensor’s policies may require approval of clinical trials involving technology invented by Licensor. Accordingly, Licensee will notify Licensor prior to commencing any clinical trials at the Licensor’s facility or any affiliated medical facilities.
3.1.5 Every year Licensor is required to report on statistics that are relevant to growth of businesses in Florida. On January 31 and pursue negotiations July 31 of each year, Licensee shall provide a report that includes: the current # of employees in Florida, the total # of employees, information about whether the company has gone public or been acquired, detail of the amount and sources of funding, any new products that have been introduced to the market, the number of employees who are USF graduates, and the number of USF interns for the period since the last report was received. This information will be held in confidence and provided in the aggregate. No confidential information will be identified with the third party. Licensee shall have the right to come into compliance within 90 days. During the notice period, Licensee may provide UFRF with a revised Development Plan with respect to the field(s) of use in question. UFRF may consider the revised Development Plan and determine, in UFRF’s sole discretion, whether the revised Development Plan will be accepted or whether the License will terminate with respect to such field(s) of use upon expiration of the notice period. [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portionsspecific company absent your agreement.
Appears in 2 contracts
Sources: Standard Exclusive License Agreement (Alzamend Neuro, Inc.), Standard Exclusive License Agreement (Alzamend Neuro, Inc.)
Development. 3.1.1 Licensee agrees to and warrants that: :
(a) it has, or will obtain, the expertise necessary to independently evaluate the inventions of the Licensed Patents; ;
(b) it will establish and actively and diligently pursue the Development Plan (see Appendix AA ) to the end that the inventions of the Licensed Patents will be utilized to provide Licensed Products and/or Licensed Processes for sale in the retail market within the Licensed Field; ;
(c) it will diligently develop markets for Licensed Products and Licensed Processes;
(d) and, until the date of first commercial sale of Licensed ProductsProducts or Licensed Processes, it will supply UFRF with a written Development Report annually fifteen (15) days after the end of the calendar year (see Appendix BB ). All development activities and strategies and all aspects of product design and [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. decisions to market and the like are entirely at the discretion of Licensee, and Licensee shall rely entirely on its own expertise with respect thereto. UFRF’s review of Licensee’s Development Plan is solely to verify the existence of Licensee’s commitment to development activity and to ensure compliance with Licensee’s obligations to commercialize the inventions of the Licensed Patents, as set forth above, other than those elements of the Development Plan as designated as Due Diligence milestones in 3.1.2 below.
3.1.2 Licensee agrees that the first commercial sale of products to the retail customer shall occur on or before January 1December 31, 2011 2016 or UFRF shall have the right to terminate the Agreement pursuant to Section 9.3 hereto. In addition, Licensee agrees to will meet the following due diligence elements which if not accomplished by the following dates, then milestones shown in Appendix D or UFRF shall have the right to terminate the Agreement pursuant to Section 9.3:. Licensee will notify UFRF in writing as each milestone is met.
(1) Complete business plan and STTR grant application 4th Q 2004
(2) Complete proof-of-concept 4th Q 2005
(3) Secure design/mfg relationship with OEM manufacturer 2nd Q 2006
(4) Potential need for VC round 2008
(5) Complete working commercial prototype 2010
(6) Hire industry CEO 2010
(7) FDA 510k approval 2011
(8) Market launch of first generation Device 2011
(9) Market launch of second generation Device 2013 If 3.1.3 Upon written request by Licensee fails to actively pursue the Development Plan with respect to a certain field(s) of use and UFRF has received notice that a third party wishes to negotiate a license for extensions of any milestones or due dates set forth in Appendix D, such field(srequest to be received by UFRF no less than ninety (90) days prior to any of usethe due dates subject of such request, set forth in this Section 3.1.3, such request fully describing Licensee’s diligent efforts to achieve the milestone required to be met by such due date, UFRF may terminate this License with respect to shall consider in good faith such field(s) of use upon sixty (60) days written notice to Licensee requests. Upon granting such request, UFRF and pursue negotiations with the third party. Licensee shall have the right to come into compliance within 90 days. During the notice period, Licensee may provide UFRF with a revised Development Plan with respect to the field(s) of use negotiate such extensions in question. UFRF may consider the revised Development Plan and determine, in UFRF’s sole discretion, whether the revised Development Plan will be accepted or whether the License will terminate with respect to such field(s) of use upon expiration of the notice period. [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portionsgood faith.
Appears in 2 contracts
Sources: Standard Exclusive License Agreement (Myriant Corp), Standard Exclusive License Agreement (Myriant Corp)
Development. 3.1.1 Licensee agrees to and warrants that: it has, or will obtain, the expertise necessary to independently evaluate the inventions of the Licensed Patents; it will establish and actively and diligently pursue the Development Plan (see Appendix A) to the end that the inventions of the Licensed Patents will be utilized to provide Licensed Products and/or Licensed Processes for sale in the retail market within the Licensed Field; and until the date of first commercial sale of Licensed Products, it will supply UFRF with a written Development Report annually fifteen (15) days after the end of the calendar year (see Appendix B). All development activities and strategies and all aspects of product design and No later than [***] Certain information prior to the anticipated registration trial for a Collaboration Product in this document has been omitted [***] whichever is earlier, solely after the Parties have reached agreement on economic terms for CMC Step 3 pursuant to Section 6.4 (including, as agreed upon by the Parties, [***]), Cue shall notify LGC whether or not it elects to have LGC perform CMC Step 3 for such Collaboration Product (“CMC Step 3 Election”). Upon the election by Cue for LGC to perform CMC Step 3 for any Collaboration Product, (i) the Parties, through the JSC, shall jointly draft, review, discuss and filed separately approve a plan that addresses the CMC Step 3 for such Collaboration Product [***] (each, a “CMC Step 3 Development Plan”), (ii) LGC (or its Affiliate, Sublicensee or subcontractor(s) appointed in accordance with Section 2.8) shall use Commercially Reasonable Efforts to conduct CMC Step 3 Development for such Collaboration Product in accordance with the Securities and Exchange Commission. Confidential treatment has been requested applicable CMC Step 3 Development Plan; (iii) with respect to the omitted portions. decisions to market and exception of Excluded Data, LGC shall provide Cue with the like are entirely at CMC Step 3 Development Package for such Collaboration Product promptly after the discretion of Licenseegeneration thereof, and Licensee shall rely entirely on at least quarterly and at least [***] business days prior to each JSC meeting disclose in writing to Cue and keep the JSC reasonably informed of all CMC Step 3 Development Data for such Collaboration Product; and (iv) subject to Article XII and Section 13.3, Cue, its own expertise with respect thereto. UFRF’s review of Licensee’s Development Plan is solely to verify the existence of Licensee’s commitment to development activity Affiliates, Sublicensees and to ensure compliance with Licensee’s obligations to commercialize the inventions of the Licensed Patentssubcontractors, as set forth aboveexcept Cue Direct Third Party Licensees, other than those elements of the Development Plan as designated as Due Diligence milestones in 3.1.2 below.
3.1.2 Licensee agrees that the first commercial sale of products to the retail customer shall occur on or before January 1, 2011 or UFRF shall have the right to terminate use and access all CMC Step 3 Development Data to Research, Develop, Manufacture and Commercialize such Collaboration Product in the Agreement pursuant to Section 9.3 heretoCue Territory as set forth in this Agreement. In additionFor avoidance of doubt, Licensee agrees to the following due diligence elements which if not accomplished unless otherwise agreed by the following datesParties in writing, then UFRF Cue Direct Third Party Licensees shall only have the right to terminate the Agreement pursuant to Section 9.3:
(1) Complete business plan Develop and STTR grant application 4th Q 2004
(2) Complete proof-of-concept 4th Q 2005
(3) Secure design/mfg relationship with OEM manufacturer 2nd Q 2006
(4) Potential need for VC round 2008
(5) Complete working commercial prototype 2010
(6) Hire industry CEO 2010
(7) FDA 510k approval 2011
(8) Market launch of first generation Device 2011
(9) Market launch of second generation Device 2013 If Licensee fails to actively pursue the Development Plan with respect to a certain field(s) of use and UFRF has received notice that a third party wishes to negotiate a license for such field(s) of use, UFRF may terminate this License with respect to such field(s) of use upon sixty (60) days written notice to Licensee and pursue negotiations with the third party. Licensee shall have the right to come into compliance within 90 days. During the notice period, Licensee may provide UFRF with a revised Development Plan with respect to the field(s) of use in question. UFRF may consider the revised Development Plan and determine, in UFRF’s sole discretion, whether the revised Development Plan will be accepted or whether the License will terminate with respect to such field(s) of use upon expiration of the notice period. [***] Certain information Commercialize Collaboration Products as set forth in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portionsAgreement.
Appears in 2 contracts
Sources: Collaboration, License and Option Agreement (Cue Biopharma, Inc.), Collaboration, License and Option Agreement (Cue Biopharma, Inc.)
Development. 3.1.1 Licensee agrees to and warrants that: :
(a) it has, or will obtain, the expertise necessary to independently evaluate the inventions of the Licensed Patents; ;
(b) it will establish and actively and diligently pursue the Development Plan (see Appendix AA ) to the end that the inventions of the Licensed Patents will be utilized to provide Licensed Products and/or Licensed Processes for sale in the retail market within the Licensed Field; ;
(c) it will diligently develop markets for Licensed Products and Licensed Processes;
(d) and, until the date of first commercial sale of Licensed ProductsProducts or Licensed Processes, it will supply UFRF with a written Development Report annually fifteen (15) days after the end of the calendar year (see Appendix BB ). All development activities and strategies and all aspects of product design and [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. decisions to market and the like are entirely at the discretion of Licensee, and Licensee shall rely entirely on its own expertise with respect thereto. UFRF’s review of Licensee’s Development Plan is solely to verify the existence of Licensee’s commitment to development activity and to ensure compliance with Licensee’s obligations to commercialize the inventions of the Licensed Patents, as set forth above, other than those elements of the Development Plan as designated as Due Diligence milestones in 3.1.2 below.
3.1.2 Licensee agrees that the first commercial sale of products to the retail customer shall occur on or before January 1May 31, 2011 2016 or UFRF shall have the right to terminate the Agreement pursuant to Section 9.3 hereto. In addition, Licensee agrees to will meet the following due diligence elements which if not accomplished by the following dates, then milestones shown in Appendix D or UFRF shall have the right to terminate the Agreement pursuant to Section 9.3:
(1) Complete business plan and STTR grant application 4th Q 2004
(2) Complete proof-of-concept 4th Q 2005
(3) Secure design/mfg relationship with OEM manufacturer 2nd Q 2006
(4) Potential need for VC round 2008
(5) Complete working commercial prototype 2010
(6) Hire industry CEO 2010
(7) FDA 510k approval 2011
(8) Market launch of first generation Device 2011
(9) Market launch of second generation Device 2013 If Licensee fails to actively pursue the Development Plan with respect to a certain field(s) of use and UFRF has received notice that a third party wishes to negotiate a license for such field(s) of use, UFRF may terminate this License with respect to such field(s) of use upon sixty (60) days written notice to Licensee and pursue negotiations with the third party. Licensee shall will notify UFRF in writing as each milestone is met.
3.1.3 Licensee agrees that three years after the Effective Date of this Agreement the Licensee will have the right to come into compliance within 90 days. During the notice period, Licensee may provide UFRF with a revised Development Plan with respect to the field(s) of use in question. UFRF may consider the revised Development Plan and determine, in UFRF’s sole discretion, whether the revised Development Plan will be accepted or whether the License will terminate with respect to such field(s) of use upon expiration achieved one of the notice periodfollowing milestones: a) Completion of at least one Sublicense for rights under the Licensed Patents or Licensed Process or b) Production of 10 Kilogram sample quantities of the Licensed Products by the Licensee. If neither of these milestones is met by the License, then the Licensee shall pay UFRF [...***...] Certain information for a one-time, non-refundable, 2-year extension to meet either milestone. Failure to meet either milestone after the 2-year extension is a material breach of this Agreement and grounds for termination pursuant to Section 9.3 hereto.
3.1.4 Upon written request by Licensee to negotiate extensions of any milestones or due dates set forth in Appendix D, such request to be received by UFRF no less than ninety (90) days prior to any of the due dates subject of such request, set forth in this document has been omitted Section 3.1.4, such request fully describing Licensee’s diligent efforts to achieve the milestone required to be met by such due date, UFRF shall consider in good faith such requests. Upon granting such request, UFRF and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portionsLicensee shall negotiate such extensions in good faith.
Appears in 2 contracts
Sources: Standard Exclusive License Agreement (Myriant Corp), Standard Exclusive License Agreement (Myriant Corp)
Development. 3.1.1 Licensee agrees to and warrants that: it has, or will obtain, the expertise necessary to independently evaluate the inventions of the Licensed Patents; it will establish and actively and diligently [***] pursue the Development Plan (see Appendix A) to the end that the inventions of the Licensed Patents will be utilized to provide Licensed Products and/or Licensed Processes for sale in the retail market within the Licensed Field; and until the date of first commercial sale of Licensed Products, it will supply UFRF with a written Development Report annually fifteen (15) days [***] after the end of the calendar year [***] (see Appendix B). All development activities and strategies and all aspects of product design and [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. decisions to market and the like are entirely at the discretion of Licensee, and Licensee shall rely entirely on its own expertise with respect thereto. UFRF’s review of Licensee’s Development Plan is solely to verify the existence of Licensee’s commitment to development activity and to ensure compliance with Licensee’s obligations to commercialize the inventions of the Licensed Patents, as set forth above, other than those elements of the Development Plan as designated as Due Diligence milestones in 3.1.2 below.
3.1.2 Licensee agrees that the first commercial sale of products to the retail customer shall occur on or before January 1, 2011 or UFRF [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. shall have the right to terminate the Agreement pursuant to Section 9.3 hereto. In addition, Licensee agrees to the following due diligence elements which if not accomplished by the following dates, then UFRF shall have the right to terminate the Agreement pursuant to Section 9.3:
(1) Complete business plan and STTR grant application 4th Q 2004
(2) Complete proof-of-concept 4th Q 2005
(3) Secure design/mfg relationship with OEM manufacturer 2nd Q 2006
(4) Potential need for VC round 2008
(5) Complete working commercial prototype 2010
(6) Hire industry CEO 2010
(7) FDA 510k approval 2011
(8) Market launch of first generation Device 2011
(9) Market launch of second generation Device 2013 : [***] If Licensee fails to actively pursue the Development Plan with respect to a certain field(s) of use and UFRF has received notice that a third party wishes to negotiate a license for such field(s) of use, UFRF may terminate this License with respect to such field(s) of use upon sixty (60) days written notice to Licensee and pursue negotiations with the third party. Licensee shall have the right to come into compliance within 90 days. During the notice period, Licensee may provide UFRF with a revised Development Plan with respect to the field(s) of use in question. UFRF may consider the revised Development Plan and determine, in UFRF’s sole discretion, whether the revised Development Plan will be accepted or whether the License will terminate with respect to such field(s) of use upon expiration of the notice period. [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
Appears in 1 contract
Development. 3.1.1 Licensee agrees to and warrants that: :
(a) it has, or will obtain, the expertise necessary to independently evaluate the inventions of the Licensed Patents; ;
(b) it will establish and actively and diligently pursue the Development Plan (see Appendix A) to the end that the inventions of the Licensed Patents will be utilized to provide Licensed Products and/or Licensed Processes for sale in the retail market within the Licensed Field; ;
(c) it will diligently develop markets for Licensed Products and Licensed Processes;
(d) until the date of first commercial sale of Licensed ProductsProducts or Licensed Processes, it will supply the UFRF with a written Development Report annually fifteen (15) days after the end of the calendar year (see Appendix B). All development activities and strategies and all aspects ;
(e) and, one year before commencement of product design and [***] Certain information manufacturing or commercial production, Licensee will include in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. decisions to market and the like are entirely at the discretion of Licensee, and Licensee shall rely entirely on its own expertise with respect thereto. UFRF’s review of Licensee’s Development Plan is solely to verify the existence of Licensee’s commitment to development activity and to ensure compliance with Licensee’s obligations to commercialize the inventions of the Licensed Patents, as set forth above, other than those elements of the Development Plan as designated as Due Diligence milestones in 3.1.2 belowReport specifics of planned manufacturing or production.
3.1.2 Licensee agrees that the first commercial sale of products to the retail customer shall occur on or before January 130th, 2011 2025 or UFRF shall have the right to terminate the Agreement pursuant to Section 9.3 hereto. In addition, Licensee agrees to will meet the following due diligence elements which if not accomplished by the following dates, then milestones shown in Appendix D or UFRF shall have the right to terminate the Agreement pursuant to Section 9.3:. Licensee will notify UFRF in writing as each milestone is met.
(1) Complete business plan and STTR grant application 4th Q 2004
(2) Complete proof-of-concept 4th Q 2005
(3) Secure design/mfg relationship with OEM manufacturer 2nd Q 2006
(4) Potential need for VC round 2008
(5) Complete working commercial prototype 2010
(6) Hire industry CEO 2010
(7) FDA 510k approval 2011
(8) Market launch of first generation Device 2011
(9) Market launch of second generation Device 2013 If 3.1.3 Upon written request by Licensee fails to actively pursue the Development Plan with respect to a certain field(s) of use and UFRF has received notice that a third party wishes to negotiate a license for extensions of any milestones or due dates set forth in Appendix D, such field(srequest to be received by UFRF no less than ninety (90) days prior to any of usethe due dates subject to such request, set forth in this Section 3.1.3, such request fully describing Licensee’s diligent effort to achieve the milestones required to be met by such due date, UFRF may terminate this License with respect to shall consider in good faith such field(s) of use upon sixty (60) days written notice to Licensee requests. Upon granting such request, UFRF and pursue negotiations with the third party. Licensee shall have negotiate such extensions in good faith.
3.1.4 University of Florida policies may require approval of clinical trials involving technologies invented at the right to come into compliance within 90 daysUniversity. During the notice periodAccordingly, Licensee may provide will notify UFRF with a revised Development Plan with respect prior to commencing any clinical trials at the field(s) University of use in question. UFRF may consider the revised Development Plan and determine, in UFRF’s sole discretion, whether the revised Development Plan will be accepted Florida or whether the License will terminate with respect to such field(s) of use upon expiration of the notice period. [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portionsits affiliated medical facilities.
Appears in 1 contract
Sources: Standard Exclusive License Agreement (XORTX Therapeutics Inc.)
Development. 3.1.1 Licensee agrees to and warrants that: :
(a) it has, or will obtain, obtain the expertise necessary to independently evaluate the inventions of the Licensed Patents; ;
(b) it will establish and actively and diligently pursue the Development Plan (see Appendix A) to the end that the inventions of the Licensed Patents will be utilized to provide Licensed Products and/or Licensed Processes for sale in the retail market within the Licensed Field; ;
(c) it will diligently develop markets for Licensed Products and Licensed Processes;
(d) and until the date of first commercial sale of Licensed ProductsProducts or Licensed Products or Licensed Processes, it will supply UFRF with a written Development Report annually fifteen (15) days after the end of the calendar year (see Appendix B). All development activities and strategies and all aspects of product design and [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. decisions to market and the like are entirely at the discretion of Licensee, and Licensee shall rely entirely on its own expertise with respect thereto. ) UFRF’s review of Licensee’s Development Plan is solely to verify the existence of Licensee’s commitment to development activity and to ensure compliance with Licensee’s obligations to commercialize the inventions of the Licensed Patents, Patents as set forth above, other than those elements of the Development Plan as designated as Due Diligence milestones in 3.1.2 below.
3.1.2 Licensee agrees that (three years after the Effective Date of this Agreement the Licensee would have achieved one of the following milestones: a) Completion of at least one sublicense for rights under the Licensed Patents or Licensed Process or b) Production of 10 Kilogram sample quantities of the License Products by the Licensee. If neither of these milestones is met by the License, then the License shall pay UFRF $12,500.00 for a one-time, non-refundable, 2-year extension to meet either milestone. Failure to meet either milestone after the 2-year extension is a material breach of this Agreement and grounds for termination pursuant to Section 9.3 hereto.
3.1.3 Licensee agrees that the first commercial sale of one or more products to the retail customer shall occur on or before January August 1, 2011 or UFRF shall have the right to terminate the Agreement pursuant to Section 9.3 9.4 hereto. In addition, Licensee agrees to will meet the following due diligence elements which if not accomplished by the following dates, then milestones shown in Appendix D or UFRF shall have the right to terminate the Agreement pursuant to Section 9.3:9.4. Licensee will notify UFRF in writing as each milestone is met.
(1) Complete business plan and STTR grant application 4th Q 2004
(2) Complete proof-of-concept 4th Q 2005
(3) Secure design/mfg relationship with OEM manufacturer 2nd Q 2006
(4) Potential need for VC round 2008
(5) Complete working commercial prototype 2010
(6) Hire industry CEO 2010
(7) FDA 510k approval 2011
(8) Market launch of first generation Device 2011
(9) Market launch of second generation Device 2013 If 3.1.4 Upon written request by Licensee fails to actively pursue the Development Plan with respect to a certain field(s) of use and UFRF has received notice that a third party wishes to negotiate a license for extensions of any Milestones Due Dates set forth in Appendix D, such field(s) of use, request to be received by UFRF may terminate this License with respect to such field(s) of use upon sixty no less than ninety (6090) days written notice prior to Licensee any of the Due Dates subject of such request, set forth in this Section 3.1.4, such request fully describing Licensees Commercially Reasonable Efforts to achieve the Milestone required to be met by such Due Date. UFRF shall consider in good faith such requests. Upon granting such requests. UFRF and pursue negotiations with the third party. Licensee shall have the right to come into compliance within 90 days. During the notice period, Licensee may provide UFRF with a revised Development Plan with respect to the field(s) of use negotiate such extensions in question. UFRF may consider the revised Development Plan and determine, in UFRF’s sole discretion, whether the revised Development Plan will be accepted or whether the License will terminate with respect to such field(s) of use upon expiration of the notice period. [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portionsgood faith.
Appears in 1 contract
Sources: Standard Exclusive License Agreement (Myriant Corp)
Development. 3.1.1 Licensee agrees to and warrants that: the following:
(a) it has, or will obtain, the expertise necessary to independently evaluate the inventions of the Licensed Patents; ;
(b) it will establish and actively and diligently pursue the Development Plan (see Appendix AA ) to the end that the inventions of the Licensed Patents will be utilized to provide Licensed Products and/or Licensed Processes for sale in the retail market within the Licensed Field; and and
(c) until the date of first commercial sale of Licensed Products, it will supply UFRF with a written Development Report annually fifteen (15) days after the end of the calendar year (see Appendix BB ). All development activities and strategies and all aspects of product design and [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. decisions to market and the like are entirely at the discretion of Licensee, and Licensee shall rely entirely on its own expertise with respect thereto. UFRF’s review of Licensee’s Development Plan is solely to verify the existence of Licensee’s commitment to development activity and to ensure compliance with Licensee’s obligations to use commercially reasonable efforts to commercialize the inventions of the Licensed Patents, as set forth above, other than those elements of the Development Plan as designated as Due Diligence milestones in 3.1.2 belowSection 3.1.3.
3.1.2 ▇▇▇▇▇ ▇▇▇▇▇▇ will act as Chief Executive Officer of Licensee agrees that as of the first commercial sale Effective Date of products to the retail customer shall occur on or before January 1, 2011 or UFRF shall have the right to terminate the this Agreement pursuant to Section 9.3 hereto. In addition, Licensee agrees to the following due diligence elements which if not accomplished and will remain as such until replaced by the following dates, then UFRF shall have the right to terminate the Agreement pursuant to Section 9.3:
(1) Complete business plan and STTR grant application 4th Q 2004
(2) Complete proof-of-concept 4th Q 2005
(3) Secure design/mfg relationship with OEM manufacturer 2nd Q 2006
(4) Potential need for VC round 2008
(5) Complete working commercial prototype 2010
(6) Hire industry CEO 2010
(7) FDA 510k approval 2011
(8) Market launch Licensee’s Board of first generation Device 2011
(9) Market launch of second generation Device 2013 If Licensee fails to actively pursue the Development Plan with respect to a certain field(s) of use and UFRF has received notice that a third party wishes to negotiate a license for such field(s) of use, UFRF may terminate this License with respect to such field(s) of use upon sixty (60) days written notice to Licensee and pursue negotiations with the third partyDirectors. Licensee shall have the right to come into compliance within 90 days. During the notice period, Licensee may provide UFRF with a revised Development Plan with respect to the field(s) of use in question. UFRF may consider the revised Development Plan and determine, in UFRF’s sole discretion, whether the revised Development Plan will be accepted or whether the License will terminate with respect to such field(s) of use upon expiration of the notice period. [***] * Certain information in this document exhibit has been omitted and will be filed separately with the Securities and Exchange Commission. Commission pursuant to a Confidential treatment has been requested with respect Treatment Request.
3.1.3 Licensee agrees to use commercially reasonable efforts to achieve the milestones described in (a)-(i) of this Section 3.1.3 (to the omitted portions.extent applicable to the Licensed Products and Licensed Processes to be developed under this Agreement) by the target dates specified in (a)-(i) below:
(a) First commercial sale of a Licensed Product to a retail customer on or before the date thirty-six (36) months from March 1, 2006;
(b) Establish facilities or enter a contract for outsourced facilities for processing tissue for transplantation and apply to the United States Food and Drug Administration (“FDA”) (or applicable governing body) for approval, if required, to use such facilities for said process, on or before August 1, 2008;
(c) If any Licensed Products or Licensed Processes are classified as a drug or biologic by the FDA, complete preclinical trials required to initiate Phase I FDA clinical trials for at least one Licensed Product or Licensed Process which is classified as a therapeutic by FDA, on or before the date fifteen (15) months from [**];
(d) If any Licensed Products or Licensed Processes are classified as a drug or biologic by the FDA, initiate Phase I clinical trials for at least one Licensed Product or Licensed Process which is classified as a therapeutic by FDA, on or before the date twelve (12) months from the date on which milestone 3.1.3
Appears in 1 contract
Sources: Standard Exclusive License Agreement (AxoGen, Inc.)
Development. 3.1.1 Licensee agrees to and warrants that: :
(a) it has, or will obtain, the expertise necessary to independently evaluate the inventions of the Licensed Patents; ;
(b) it will establish and actively and diligently pursue the Development Plan (see Appendix AB) to the end that the inventions of the Licensed Patents will be utilized to provide Licensed Products and/or Licensed Processes for sale in the retail market within the Licensed Field;
(c) it will diligently develop markets for Licensed Products and Licensed Processes; and and
(d) until the date of first commercial sale of Licensed ProductsProducts or Licensed Processes, it will supply UFRF FSURF with a written Development Report annually fifteen (15) days after the end of the calendar year (see Appendix BC). All development activities and strategies and all aspects of product design and [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. decisions to market and the like are entirely at the discretion of Licensee, and Licensee shall rely entirely on its own expertise with respect thereto. UFRF’s review of Licensee’s Development Plan is solely to verify the existence of Licensee’s commitment to development activity and to ensure compliance with Licensee’s obligations to commercialize the inventions of the Licensed Patents, as set forth above, other than those elements of the Development Plan as designated as Due Diligence milestones in 3.1.2 below.
3.1.2 Licensee agrees that the first commercial sale of products to the retail customer shall occur on or before January 1, 2011 [***] or UFRF FSURF shall have the right to terminate the Agreement pursuant to Section 9.3 hereto. In addition, Licensee agrees to pay the following product development milestone payments listed in Section 4.3.3 and to complete the due diligence elements which if not accomplished by the following dates, then UFRF activities listed in Appendix E or FSURF shall have the right to terminate the Agreement pursuant to Section 9.3:. Licensee will notify FSURF in writing as each milestone or due diligence activity is met.
(1) Complete business plan and STTR grant application 4th Q 2004
(2) Complete proof-of-concept 4th Q 2005
(3) Secure design/mfg relationship with OEM manufacturer 2nd Q 2006
(4) Potential need for VC round 2008
(5) Complete working commercial prototype 2010
(6) Hire industry CEO 2010
(7) FDA 510k approval 2011
(8) Market launch of first generation Device 2011
(9) Market launch of second generation Device 2013 If 3.1.3 Licensee fails to actively pursue the Development Plan with respect to may issue a certain field(s) of use and UFRF has received notice that a third party wishes written request to negotiate a license extensions of individual milestones listed in Section 4.3.3 or due dates for individual due diligence activities listed in Appendix E. Provided that such field(s) of use, UFRF may terminate this License with respect to such field(s) of use upon sixty requests are received by FSURF no less than ninety (6090) days written notice prior to Licensee the original due date in the case of milestone payments, or no less than forty five (45) days prior to the original due date in the case of due diligence activities, and pursue negotiations with that each request describes fully Licensee’s diligent efforts to achieve the third partymilestones or complete the due diligence activities, FSURF shall consider in good faith such requests. Upon granting each such request, FSURF and Licensee shall have negotiate in good faith the right length of the extension. FSURF shall not unreasonably withhold requests to come into compliance within 90 daysnegotiate extensions.
3.1.4 Florida State University policies may require approval of clinical trials involving technology invented at the University. During the notice periodAccordingly, Licensee may provide UFRF with a revised Development Plan with respect will notify FSURF prior to the field(s) of use in question. UFRF may consider the revised Development Plan and determine, in UFRF’s sole discretion, whether the revised Development Plan will be accepted commencing any clinical trials at Florida State University or whether the License will terminate with respect to such field(s) of use upon expiration of the notice period. [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portionsits affiliated medical facilities.
Appears in 1 contract
Sources: Standard Exclusive License Agreement (Spotlight Innovation, Inc.)
Development. 3.1.1 Licensee agrees to and warrants that: :
(a) it has, or will obtain, obtain the expertise necessary to independently evaluate the inventions of the Licensed Patents; ;
(b) it will establish and actively and diligently pursue the Development Plan (see Appendix A) to the end that the inventions of the Licensed Patents will be utilized to provide Licensed Products and/or Licensed Processes for sale in the retail market within the Licensed Field; ;
(c) it will diligently develop markets for Licensed Products and Licensed Processes;
(d) and until the date of first commercial sale of Licensed ProductsProducts or Licensed Products or Licensed Processes, it will supply UFRF with a written Development Report annually fifteen (15) days after the end of the calendar year (see Appendix B). All development activities and strategies and all aspects of product design and [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. decisions to market and the like are entirely at the discretion of Licensee, and Licensee shall rely entirely on its own expertise with respect thereto. ) UFRF’s review of Licensee’s Development Plan is solely to verify the existence of Licensee’s commitment to development activity and to ensure compliance with Licensee’s obligations to commercialize the inventions of the Licensed Patents, Patents as set forth above, other than those elements of the Development Plan as designated as Due Diligence milestones in 3.1.2 below.
3.1.2 Licensee agrees that (three years after the Effective Date of this Agreement the Licensee would have achieved one of the following milestones: a) Completion of at least one sublicense for rights under the Licensed Patents or Licensed Process or b) Production of 10 Kilogram sample quantities of the License Products by the Licensee. If neither of these milestones is met by the License, then the License shall pay UFRF $[...***...] for a one-time, non-refundable, 2-year extension to meet either milestone. Failure to meet either milestone after the 2-year extension is a material breach of this Agreement and grounds for termination pursuant to Section 9.3 hereto.
3.1.3 Licensee agrees that the first commercial sale of one or more products to the retail customer shall occur on or before January August 1, 2011 or UFRF shall have the right to terminate the Agreement pursuant to Section 9.3 9.4 hereto. In addition, Licensee agrees to will meet the following due diligence elements which if not accomplished by the following dates, then milestones shown in Appendix D or UFRF shall have the right to terminate the Agreement pursuant to Section 9.3:9.4. Licensee will notify UFRF in writing as each milestone is met.
(1) Complete business plan and STTR grant application 4th Q 2004
(2) Complete proof-of-concept 4th Q 2005
(3) Secure design/mfg relationship with OEM manufacturer 2nd Q 2006
(4) Potential need for VC round 2008
(5) Complete working commercial prototype 2010
(6) Hire industry CEO 2010
(7) FDA 510k approval 2011
(8) Market launch of first generation Device 2011
(9) Market launch of second generation Device 2013 If 3.1.4 Upon written request by Licensee fails to actively pursue the Development Plan with respect to a certain field(s) of use and UFRF has received notice that a third party wishes to negotiate a license for extensions of any Milestones Due Dates set forth in Appendix D, such field(s) of use, request to be received by UFRF may terminate this License with respect to such field(s) of use upon sixty no less than ninety (6090) days written notice prior to Licensee any of the Due Dates subject of such request, set forth in this Section 3.1.4, such request fully describing Licensees Commercially Reasonable Efforts to achieve the Milestone required to be met by such Due Date. UFRF shall consider in good faith such requests. Upon granting such requests. UFRF and pursue negotiations with the third party. Licensee shall have the right to come into compliance within 90 days. During the notice period, Licensee may provide UFRF with a revised Development Plan with respect to the field(s) of use negotiate such extensions in question. UFRF may consider the revised Development Plan and determine, in UFRF’s sole discretion, whether the revised Development Plan will be accepted or whether the License will terminate with respect to such field(s) of use upon expiration of the notice period. [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portionsgood faith.
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Sources: Standard Exclusive License Agreement (Myriant Corp)