Xxxxx Indication Sample Clauses

Xxxxx Indication. (i) XXXXX shall have the right to continue to develop the Compound for the Xxxxx Indication, as expressly provided in this Section 4.3 and the Transition Plan. XXXXX shall have the right to (x) continue and complete its current Phase II trial for the Xxxxx Indication as in effect on the date hereof under the Transition Plan (the “Existing Phase II Xxxxx Indication Plan”), (y) subject to PFIZER’s approval through the Xxxxx Indication Committee (as defined below), modify and/or expand the trial design for the Existing Phase II Xxxxx Indication Plan (any and all such modifications or expansions, being hereinafter referred to as the “Expanded Phase II Xxxxx Indication Plan”) and implement the Expanded Phase II Xxxxx Indication Plan in accordance with such plan and (z) subject to PFIZER’s approval of the Phase III Xxxxx Indication Plan (as defined below) through the Xxxxx Indication Committee, conduct the Phase III Clinical Study for the Xxxxx Indication in accordance with the Phase III Xxxxx Indication Plan, beginning on the first anniversary of the commencement by PFIZER of the Phase III Clinical Study for NSCLC. By no later than December 31, 2005, XXXXX shall deliver to PFIZER a detailed draft of its Phase III development plan for Compound for the Xxxxx Indication (such plan, as approved and amended from time to time by the Xxxxx Indication Committee, the “Phase III Xxxxx Indication Plan”). All of XXXXX’x development plans and activities (including, without limitation, all protocols, clinical study reports and budgets) for the Compound for the Xxxxx Indication and any material modifications thereto or implementation thereof are subject to approval by PFIZER in its reasonable discretion through the Xxxxx Indication Committee.
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Related to Xxxxx Indication

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  • Licensed Products Lessee will obtain no title to Licensed Products which will at all times remain the property of the owner of the Licensed Products. A license from the owner may be required and it is Lessee's responsibility to obtain any required license before the use of the Licensed Products. Lessee agrees to treat the Licensed Products as confidential information of the owner, to observe all copyright restrictions, and not to reproduce or sell the Licensed Products.

  • Regulatory Approval Any waiting period applicable to the Transactions under the HSR Act shall have been terminated or shall have expired.

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  • Product Recall (a) If any governmental agency with jurisdiction over the recall of any goods supplied hereunder provides written notice to Buyer or Seller, or Buyer or Seller has a reasonable basis to conclude, that any goods supplied hereunder could possibly create a potential safety hazard or unsafe condition, pose an unreasonable risk of serious injury or death, contain a defect or a quality or performance deficiency, or are not in compliance with any applicable code, standard or legal requirement so as to make it advisable, or required, that such goods be recalled and/or repaired, Seller or Buyer will promptly communicate such relevant facts to each other. Buyer shall determine whether a recall of the affected goods is warranted or advisable, unless Buyer or Seller has received notice to that effect from any governmental agency with jurisdiction over the recalled goods.

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