Commercial Diligence and Milestones. Upon execution of this Agreement, Licensee shall proceed with Commercially Reasonable Efforts to develop, manufacture, practice, sell and use the Licensed Products and/or Licensed Methods in order to make them readily available to the general public as soon as practicable on commercially reasonable terms. Licensee shall continue Commercially Reasonable Efforts for one or more Licensed Product(s) and/or Licensed Method(s) throughout the term of this Agreement (“Actively Commercializing”). In addition, Licensee shall perform at least the following obligations as part of its due diligence activities hereunder:
a. Licensee shall achieve the following milestones during the course of its operations:
1. [†] – The PAM50 Product or another Licensed Product or Licensed Method [†] by Licensee or its Affiliates or Sublicensees. For purposes of this Section 5.1(a)(1), the PAM50 Product or another Licensed Product or Licensed Method [†] by Licensee or its Affiliates or Sublicensees if Licensee or its Affiliates or Sublicensees [†] the PAM50 Product or another Licensed Product or Licensed Method.
2. [†] – Licensee or its Affiliates or Sublicensee [†] the PAM50 Product or another Licensed Product or Licensed Method. For purposes of this milestone, [†]. Licensee, itself or through its Affiliates or Sublicensees, may satisfy the requirement that it [†].
3. [†] – Either (A) Licensee or its Affiliates or Sublicensee [†] the PAM50 Product or another Licensed Product or Licensed Method or (B) [†] the † DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION PAM50 Product or another Licensed Product or Licensed Method [†] by Licensee or its Affiliates or Sublicensees. For purposes of the foregoing clause (B), it shall only be necessary that such [†]. By way of illustration and not limitation, the milestone set forth in the foregoing clause (B), shall be satisfied if [†], Licensee or its Affiliates or Sublicensees [†] the PAM50 Product or another Licensed Product or Licensed Method.
4. [†] – Licensee or its Affiliates or Sublicensee will make Commercially Reasonable Efforts to [†] the PAM50 Product or another Licensed Product or Licensed Method. The [†] the PAM50 Product or another Licensed Product or Licensed Method also shall constitute achievement of all milestones set forth in Sections 5.1(a)(1), 5.1(a)(2) and 5.1(a)(3).
b. Licensee represents and warrants to Licensor that as of the Effe...
Commercial Diligence and Milestones. 4.1 LICENSEE shall use commercially reasonable efforts to develop, manufacture, market and sell Product in the Territory and will exert commercially reasonable efforts to create a demand for Product.
4.2 LICENSEE agrees to submit annual reports, as to its efforts to develop Product and markets for Product. Such reports shall include assurance by LICENSEE of its intent to actively develop commercial embodiments of the Patent Rights and a summary of its efforts in this regard.
4.3 LICENSEE, at its sole expense, shall make commercially reasonable efforts to accomplish the following:
(a) by the first day of the [*****] anniversary of Effective Date, pre-IND meeting with FDA (or correlate submission to regulatory organization in other country);
(b) by the first day of the [*****] anniversary of Effective Date, IND submission to FDA (or correlate submission to regulatory organization in other country); and
(c) by the first day of the [*****] anniversary of Effective Date, first subject treated in a phase I clinical trial
(d) LICENSEE, upon written request to UNIVERSITY, may be granted an extension of one or more of the above milestones (a)-(c) by six (6) months up to three (3) times for a total possible extension of eighteen (18) months provided LICENSEE pays UNIVERSITY a payment of a [*****] fee per extension. If LICENSEE extends a particular milestone, all subsequent milestones will be extended by the same time period.
(e) The Parties agree to the following milestones and payments but not more than once even if the milestone is accomplished for more than one Product in the Territory. For the avoidance of doubt, if the same milestone is achieved by a Sublicensee of the Patent Rights, then UNIVERSITY shall share in any payments LICENSEE receives from a Sublicensee according to section 3.4 above, and the following milestones and payments will not be due. The following milestone payments shall not be creditable towards any other monies UNIVERSITY is due from LICENSEE, including but not limited to: payment of past patent costs, payment of future patent costs, royalty payments, and royalty payments associated with a Sublicensee's sale of any Product(s):
(f) Upon dosing of the first patient in the first phase I clinical trial conducted by Licensee based upon the Patent Rights in the Field of Use, LICENSEE shall pay UNIVERSITY an additional amount of [*****]
(g) Upon dosing of the first patient in the first phase II clinical trial conducted by Licensee based upon the ...
Commercial Diligence and Milestones. 4.1 LICENSEE shall use commercially reasonable efforts to manufacture, market and sell the Products in the Territory and will exert commercially reasonable efforts to create a demand for the Products.
4.2 LICENSEE agrees to submit annual reports, as to its efforts to develop markets for the licensed Products. Such reports shall include assurance by LICENSEE of its intent to actively develop commercial embodiments of the Patent Rights and a summary of its efforts in this regard.
4.3 LICENSEE shall at its sole expense, make commercially reasonable efforts to accomplish the following:
a. Submit an Investigational New Drug application to the FDA, or international equivalent, within one (1) year of the Effective Date of this Agreement;
b. Initiate a clinical trial utilizing Bone Marrow Derived CD271 Precursor Cells within three (3) years of the Effective Date of this Agreement;
c. LICENSEE may extend any of the above milestones (a)-(d) by six months up to three (3) times (for a total possible extension of eighteen (18) months) by notice to JMHMD and payment of a five thousand dollar ($5,000.00) extension fee per extension. If LICENSEE extends a particular milestone, all subsequent milestones will be extended by the same time period.
4.4 Subject to any applicable cure period, LICENSEE agrees that JMHMD may terminate this Agreement in its sole discretion in the event that LICENSEE fails to perform any of the obligations contained in this Paragraph 4 within five (5) years of the Effective Date of this Agreement.
Commercial Diligence and Milestones. 4.1 LICENSEE shall use commercially reasonable efforts to develop, manufacture, market and sell Product in the Territory and will exert commercially reasonable efforts to create a demand for Product,
4.2 LICENSEE agrees to submit annual reports, as to its efforts to develop Product and markets for Product. Such reports shall Include assurance by LICENSEE of its Intent to actively develop commercial embodiments of the Technology Rights and a summary of its efforts in this regard.
4.3 LICENSEE, at Its sole expense, shall make commercially reasonable efforts to accomplish the following:
(i) by December 31, 2017, to have completed Phase II clinical trials for the Products; and
(ii) by December 31, 2020, to have completed Phase III clinical trials for the Products.
b. LICENSEE, upon written request to UNIVERSITY, may be granted an extension of one or more of the milestones above by six (6) months up to three (3) times for a total possible extension of eighteen (18) months provided LICENSEE pays UNIVERSITY a payment of a Five Thousand Dollars ($5,000.00) fee per extension. If LICENSEE extends a particular milestone, all subsequent milestones will be extended by the same time period.
c. The Parties agree to the following milestones and payments. For the avoidance of doubt, if the same milestone is achieved by a Sublicensee of the Technology Rights, then UNIVERSITY shall share In any payments LICENSEE receives from a Sublicensee according to Section 3,5 above, and the following milestones and payments will not be due. The following milestone payments shall not be creditable towards any other monies UNIVERSITY is due from LICENSEE, including but not limited to: payment of past Technology Rights costs, payment of future Technology Rights costs, royalty payments, and royalty payments associated with a Sub licensee’s sale of any Product(s):
d. Upon reaching milestones in subsection 4.3 a, LICENSEE will pay UNIVERSITY as follows:
(i) Upon completion of Phase II clinical trials for the Products, two hundred and fifty thousand dollars ($250,000); and
(ii) Upon completion of Phase IR clinical trials for the Products, seven hundred and fifty thousand dollars ($750,000).
4.4 In the event that either Party is prevented from performing under the Agreement as a result of an act of God, hurricane, war, or terrorism, any delays In or failure of performance under the Agreement shall be excused If and to the extent that such delays or failures are beyond such Party’s reasonable co...
Commercial Diligence and Milestones
