Common use of Further Development Clause in Contracts

Further Development. 12.1. Development Cost for the European Union Licensor shall perform the work described in the Licensor Clinical Development Plan, on the schedule described therein in accordance with all applicable laws, rules, regulations, and International Conference on Harmonisation ("ICH") guidelines, including but not limited to Good Clinical Practices ("GCP") and Good Laboratory Practices ("GLP") guidelines, as reasonably appropriate. Material changes to the Licensor Clinical Development Plan may only be made upon the approval of the Committee (defined below). 12.2. Consideration to Licensor for EU Clinical Development Subject to Clause 12.3, in consideration for the work described In Clause 12.1, Licensee shall reimburse Licensor for reasonable, documented, direct costs and expenses of performing such work described in the Licensor Clinical Development Plan incurred subsequent to the Effective Date and pursuant to the budget established therein, as they are reasonably incurred, upon presentment of invoices therefore to Licensee, provided, however, that Licensee's total payment obligation under this Agreement with respect to such costs and expenses shall not in any event exceed (i) US$2,800,000 to be used by Licensor for the Anoheal Project (the "Maximum Anoheal Amount) and (ii) US$1,200,000 to be used by the Licensor for the Incostop Project (the "Maximum Incostop Amount"). It is understood that such costs shall be invoiced to the Licensee on a monthly basis and shall include the actual costs for the Licensor's professional services (including proportions of employees remuneration, travel, office and other related expenses determined in good faith) incurred by Licensor in connection with the development of Anoheal and Incostop (as applicable). Invoices for Third Party goods and services may at Licensor's discretion (i) be paid by Licensor and reimbursed by Licensee or (ii) be directed to Licensee for direct payment. The Licensee irrevocably undertakes to settle all invoices issued by or directed for payment by the Licensor within thirty (30) days of receipt thereof. The Licensee shall remit $50,000 to the Licensor upon execution of this Agreement for reimbursement of clinical development costs of Licensor, such amount to be credited toward either the Maximum Incostop Amount or the Maximum Anoheal Amount at Licensor's discretion. Licensor shall account for its use of funds provided to it by Licensee pursuant to this Clause 12.2 separately between the Incostop Project and the Anoheal Project, such records to be provided to the Licensee quarterly. 12.3. Termination of Expense Payments 12.3.1. In the event that the Licensor discontinues the portion of the Licensor Clinical Development Plan relating to the Anoheal Project arid/or the Incostop Project, then the Licensee shall have no further payment obligation with respect to the applicable project other than to pay for uncancellabie financial commitments made prior to such discontinuance relating to the applicable discontinued program. Additionally, in the event that the Licensee discontinues the Licensee Clinical Development Plan relating to the Incostop Project and/or the Anoheal Project, then the Licensee's payment obligations pursuant to Clause 12.2 shall terminate with respect to the corresponding project under the Licensor Clinical Development Plan, other than to pay for uncancellable financial commitments made prior to such discontinuance relating to such discontinued program, and upon such payment, the balance of the Maximum Incostop Amount (in the case of termination of the Incostop Project) or the Maximum Anoheal Amount (in the case of termination of the Anoheal Project) shall be zero.