Diligence Milestone has the meaning set forth in Section 3.1(b).
Diligence Milestone means, with respect to any table for a Licensed Product in Exhibit D, each milestone event described in the “Milestone” column of any row of such table.
Diligence Milestone shall have the meaning set forth in Section 3.5 of this Agreement.
Examples of Diligence Milestone in a sentence
Licensor acknowledges that due to long development times, scientific, potential safety and development hurdles and challenges and regulatory requirements and processes associated with Licensee’s industry, Licensee may be unable to achieve a particular Diligence Milestone by the applicable Achievement Date.
More Definitions of Diligence Milestone
Diligence Milestone. On or before the six month anniversary of the Effective Date, LICENSEE will have completed assumed lease to prior AGT facilities or otherwise acquired other facilities to continue development and commercialization of the Licensed Technology.
Diligence Milestone means each of the outcomes referenced under “Milestone” below relating to the Development Program for the Compound, along with the deadline for achieving the particular outcome referenced under “Deadline” in the right hand column opposite that outcome. The Parties acknowledge and agree that the Diligence Milestones set forth below are specified herein solely for purposes of conclusively establishing that if Avalon should fail to achieve a Diligence Milestone by the specified Deadline date, Avalon has not satisfied the requirements of this Section 3.6. However, completion of a Diligence Milestone on or about the corresponding deadline shall not be considered presumptive evidence that Avalon shall have satisfied its general development obligations as set forth in the first paragraph of this Section 3.6. Milestone Deadline IND Filed with FDA * (subject to extension under Section 4.2) Initiate Phase Ib Clinical Trial Within * after the FDA Accepts the IND Initiate a Phase II Clinical Trial No later than * after the LPO of the Phase Ib Clinical Trial Initiate Pivotal Registration Study No later than * after Phase II FDA Meeting If the first Pivotal Registration Study trial is unsuccessful, the commencement of a follow on Pivotal Registration Study No later than * after the LPO of the unsuccessful Pivotal Registration Study File NDA in a Major Market country No later than * after LPO of the successful Pivotal Registration Study (or Studies) for the lead Indication File application for Regulatory Approval in all Major Market countries (in which Avalon has retained rights to the Compound) except Japan No later than * after LPO of the Pivotal Registration Study (or Studies) leading to the filing of an NDA in a Major Market Country for the lead Indication File application for Regulatory Approval in Japan (assuming that Avalon has retained rights to the Compound in Japan) No later than * after LPO in the Pivotal Registration Study (or Studies) for the lead Indication * The asterisk denotes the confidential portions of this document that have been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. For example, a Diligence Milestone would be achieved if an IND is filed with the FDA on or before * (or, if such date is extended pursuant to Section 4.2). It would not be achieved if an IND is not filed with the FDA on or before * (or, if such date is extended pursuant to Section 4.2). Ava...
Diligence Milestone has the meaning set forth in Section 2.5.4.
Diligence Milestone has the meaning set forth in Section 4.3(b) (Specific Diligence Events).
Diligence Milestone. [EXAMPLES: “On or before the anniversary of the Effective Date, LICENSEE shall ” OR “During the -month/year period beginning on the anniversary of the Effective Date and during each succeeding -month/year period, LICENSEE shall ”]
Diligence Milestone. 2. Two (2) years from the Effective Date Licensee to receive proceeds of not less than $* million through any combination of: (i) Net Proceeds of Equity Financings, (ii) unrestricted grants or gifts and (iii) up to $* million in payments for reimbursement of sponsored research activities.