1.66“MAA” means a marketing authorization application or equivalent application to obtain Regulatory Approval, and all amendments and supplements thereto, filed with the applicable Regulatory Authority in any country or jurisdiction.
1.67“Net Sales” means [***].
1.68“New Indication” means [***].
1.69“Non-Compete Restrictions Agreement” means [***].
1.70“Orphan Indication” means an Indication that affects fewer than two hundred thousand (200,000) people each year in the United States.
1.71“Patent Proceeding” means any proceeding before a patent office related to the post-grant review of any Patent Right, including any post-grant proceeding brought pursuant to the America Invents Act (such as any inter partes review, post-grant review, opposition, interference, re-examination), or any foreign equivalent thereof. Any appeal, action, or proceeding related to a Patent Right that is brought before any court of competent jurisdiction will be deemed a “Patent Proceeding”; provided that prosecution activities including any ex parte examination and ex parte re-issue examination, appeal of ex parte patent prosecution decisions to a court or a board of a patent office, or supplemental examination before the U.S. Patent Office will not be considered a “Patent Proceeding.”
1.72“Patent Right” means (a) any national, regional, or international patent or patent application, including any provisional patent application, (b) any patent application filed either from such a patent, patent application, or provisional application or from an application claiming priority from any of these, including any divisional, continuation, continuation-in-part, provisional, converted provisional, and continued prosecution application, (c) any patent that has issued or in the future issues from any of the foregoing patent applications ((a) and (b)), including any utility model, petty patent, design patent, and certificate of invention, (d) any extension or restoration by existing or future extension or restoration mechanisms, including any revalidation, reissue, re-examination, and extension (including any supplementary protection certificate and the like) of any of the foregoing patents or patent applications ((a), (b), and (c)), and (e) any similar rights, including so called pipeline protection, or any importation, revalidation, confirmation or introduction patent, or registration patent or patent of additions to any such foregoing patent application or patent.
1.73“Person” means any individual, partnership, joint venture, limited liability company, corporation, firm, trust, association, unincorporated organization, Regulatory Authority, or any other entity not specifically listed in this definition.
1.74“Personnel Costs” means, for a given period, the FTE Rate multiplied by the number of FTEs actually expended to conduct activities under this Agreement during such period. FTEs will be pro-rated on a daily or hourly basis if necessary.
1.75“Pricing and Reimbursement Approval” means the later of (a) the approval, agreement, determination, or governmental decision establishing a price for a pharmaceutical or biologic product that can be legally charged to consumers, if required in a given jurisdiction or country for the Commercialization of such pharmaceutical or biologic product in such jurisdiction or country; and (b) the approval, agreement, determination, or governmental decision establishing the level of reimbursement for a pharmaceutical or biologic product that will be reimbursed by governmental authorities, if either required or otherwise