(ii) If the Licensed Product is sold independently of the Additional Active in such country, but the public or list price of the Additional Active cannot be determined, Net Sales will be calculated by multiplying the total Net Sales (as described above) of such Combination Product by the fraction A/C, where A is the public or list price in such country of such Licensed Product sold independently and C is the public or list price in such country of the Combination Product.
(iii) If the Additional Active is sold independently of the Licensed Product therein in such country, but the public or list price of such Licensed Product cannot be determined, Net Sales will be calculated by multiplying the total Net Sales (as described above) of such Combination Product by the fraction 1-B/C, where B is the (sum of the) public or list price in such country of the Additional Active and C is the public or list price in such country of the Combination Product.
(iv) If the Licensed Product and Additional Active are not sold independently in such country, Net Sales will be calculated by multiplying the total Net Sales (as described above) of such Combination Product by a fraction [***]. If [***].
1.55 “Patent Prosecution” means activities directed to (a) preparing, filing and prosecuting applications (of all types) for any Patent Rights, (b) managing any interference, opposition, re-issue, reexamination, supplemental examination, administrative invalidation proceedings (including inter partes or post-grant review proceedings), revocation, nullification, or cancellation proceeding relating to the foregoing, (c) abandoning or maintaining Patent Rights, and (d) settling any interference, opposition, reexamination, administrative invalidation, revocation, nullification or cancellation proceeding, and any appeals therefrom. [***]
1.56 “Patent Rights” means the rights and interests in and to issued patents and pending patent applications (which, for purposes of this Agreement, include certificates of invention, applications for certificates of invention and priority rights) in any country or region, including all provisional applications, substitutions, continuations, continuations-in-part, continued prosecution applications including requests for continued examination, divisional applications and renewals, and all letters patent or certificates of invention granted thereon, and all reissues, reexaminations, extensions (including pediatric exclusivity patent extensions), term restorations, renewals, substitutions, confirmations, registrations, revalidations, revisions and additions of or to any of the foregoing, in each case, in any country.
1.57 “Person” means any individual, corporation, company, partnership, association, joint-stock company, trust, unincorporated organization or government or political subdivision thereof.
1.58 “PMDA” means the Pharmaceuticals and Medical Devices Agency (of Japan), or any successor agency thereto performing similar functions.
1.59 “PRC” means the People’s Republic of China, which for the purposes of this Agreement shall exclude Hong Kong, Macau and Taiwan.
1.60 “Region” means [***].
1.61 “Regulatory Approval” means all approvals from the relevant Regulatory Authority necessary to initiate marketing and selling a product (including Licensed Product) in any country.
1.62 “Regulatory Authority” means any competent Governmental Authority with authority over the authorization, approval, distribution, importation, exportation, manufacture, production, use, storage, transport, clinical testing, promotion or sale of a pharmaceutical product (including any Licensed Product) and over interactions with healthcare professionals and healthcare organizations, which may include the authority to grant the required reimbursement and pricing approvals for such sale.
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