Common use of Early Access Programs Clause in Contracts

Early Access Programs. Pharmacyclics shall be permitted to undertake Early Access Programs for the Products in the Field in the United States and JBI shall be permitted to undertake Early Access Programs for the Products in the Field in the License Territory. If either Party desires to undertake an Early Access Program in accordance with this Section 5.12, such Party shall submit to the JDC a proposal for such Early Access Program, which proposal shall include the clinical methodology, monitoring requirements and funding budget for such Early Access Program. If the JDC agrees to an Early Access Program proposal, such proposal shall be submitted to the JSC for review and approval. The JSC shall approve such Early Access Program proposal unless the JSC determines in good faith that the proposed Early Access Program could adversely affect the Development or Commercialization of the Products in the Field in the United States or the License Territory. The Parties’ costs and expenses incurred in performing Early Access Programs that have been approved by the JSC in accordance with this Section 5.12 shall be taken into account in determining Pre-Tax Profit or Loss as, and to the extent, provided for as EAP Expenses in the Financial Exhibit.

Early Access Programs. Pharmacyclics shall be permitted to Genmab and Licensee may undertake Early Access Programs for the Licensed Products in the Field in the United States [*] and JBI shall be permitted to Licensee (and, if Genmab exercises its rights under clause 7.3.2, Genmab) may undertake Early Access Programs for the Licensed Products in the Field in the License Territory[*]. If either Party desires to undertake an Early Access Program in accordance with this Section 5.12clause 7.12, such Party shall submit to the JDC JMAS a proposal for such Early Access Program, which proposal shall include the clinical methodology, monitoring requirements and funding budget budgets for such Early Access Program. If the JDC JMAS agrees to an Early Access Program proposal, such proposal shall be submitted to the JSC JDC for review and to the JSC for approval. The JSC shall approve such Early Access Program proposal unless the JSC determines in good faith that the proposed Early Access Program could adversely affect the Development or Commercialization of the Licensed Products in the Field in the United States Territory A or the License Territory. Territory B. The Parties’ costs and expenses incurred in performing Early Access Programs that have been approved by the JSC in accordance with this Section 5.12 clause 7.12 shall be taken into account in determining Pre-Tax Profit or Loss Shared Costs as, and to the extent, provided for as EAP Expenses in the Financial Exhibitclause 8.