definiens: shall mean any occurrence beyond the reasonable con trol of a Party that prevents or substantially interferes with the performance by th e Party of any of its obligations hereunder, if suc h occurs by reason of any act of God, flood, fire, explosion, b reakdown of plant, earthquake, strike, lockout, lab or dispute, casualty or accident, or war, revolution, civil com motion, acts of public enemies, blockage or embargo, or any unforeseen delays associated with clinical trials o f the Afecta Licensed Product, or any injunction, l aw, order, proclamation, regulation, ordinance, demand or requ irement of any government or of any subdivision inc luding but not limited to the requirements and conditions of the Food and Drug Administration of the United S tates, authority or representative or any such government, inability to procure or use materials, including b ut not limited to any material needed to manufacture any A fecta Licensed Product, labor, equipment, transport ation, or energy sufficient to meet manufacturing needs witho ut the necessity of allocation, or any other cause whatsoever, whether similar or dissimilar to those above enumerated, beyond the reasonable control of such Party, if and only if the Party affected shall have used reasonable efforts to avoid such occurrence a nd to remedy it promptly if it shall have occurred and shall hav e notified the other Party in writing of the reason s for the delay or default