1.226 “Other Ingredients or Agents Information” means, with respect to a Licensed Product that is Exploited as Combination Product or as part of a Combination Therapy, Information related to (a) any Other Ingredient used in such Combination Product, or the Exploitation thereof, or (b) any Other Agent used in such Combination Therapy, or the Exploitation thereof, but excluding, in the case of (b), such Information specifically related to the use of such Licensed Product with (i) such Other Agent or (ii) any molecule, agent, compound or product in the same class of molecules, agents, compounds or products, as applicable, as such Other Agent. As used herein, a molecule, agent, compound or product is in the same class of another molecule, agent, compound or product if and only if these compounds, molecules, agents or products (1) are Directed to the same Target, (2) are or would be subject to the same type of Regulatory Approval in the U.S. (i.e., NDA vs BLA), and (3) is developed for, have received Regulatory Approval for (or Regulatory Approval has been sought for) the same indication or class of indications.
1.227 “Other Ingredients or Agents Patents” means, with respect to a Licensed Product that is Exploited as Combination Product or part of a Combination Therapy, Patents that claim (a) any Other Ingredient used in such Combination Product, or the Exploitation thereof, or (b) any Other Agent used in such Combination Therapy, or the Exploitation thereof, but excluding, in each case ((a) and (b)), such Patents to the extent that they claim the use of such Licensed Product with (i) such Other Ingredient or Other Agent or (ii) any molecule, agent, compound or product in the same class of molecules, agents, compounds or products, as applicable, as the Other Ingredient or Other Agent. As used herein, a molecule, agent, compound or product is in the same class of another molecule, agent, compound or product if and only if these molecules, agents, compounds or products (1) are Directed to the same Target, (2) are or would be subject to the same type of Regulatory Approval in the U.S. (i.e., NDA vs BLA), and (3) is developed for, have received Regulatory Approval for (or Regulatory Approval has been sought for) the same indication or class of indications.
1.228 “Out-of-Pocket Costs” means, with respect to certain activities hereunder, direct expenses paid or payable by either Party or its Affiliates to Third Parties and specifically identifiable and incurred to conduct Development, Manufacturing or Commercialization under this Agreement, as applicable, including payments to contract personnel; provided that Out-of-Pocket Costs shall not include any FTE Costs or any costs for general overhead, postage, communications, photocopying, printing or internet expense, professional dues, operating supplies, laboratory supplies, printers, photocopiers, fax machines or other office equipment, laboratory equipment, computers or computer service charges or any costs that are subsumed within the definition of Included FTE Costs and Expenses.
1.229 “Party” and “Parties” have the meaning set forth in the preamble hereto.
1.230 “Patent Challenge” has the meaning set forth in Section 15.2.6.
1.231 “Patents” means: (a) all national, regional and international patents and patent applications, including provisional patent applications and rights to claim priority from any such patents or patent applications; (b) all patent applications filed either from such patents, patent applications or provisional applications or from an application claiming priority from either of these, including divisionals, continuations, continuations-in-part, provisionals, converted provisionals and continued prosecution applications; (c) any and all patents that have issued or in the future issue from the foregoing patent applications ((a) and (b)), including utility models, petty patents, innovation patents and design patents and certificates of invention; (d) any and all extensions or restorations by existing or future extension or restoration mechanisms, including revalidations, reissues, re-examinations and extensions (including any patent term extension, pediatric exclusivity, supplementary protection certificates and the like) of the foregoing patents or patent applications ((a), (b) and (c)); and (e) any similar rights, including so-called pipeline protection or registration patent of any of such foregoing patent applications and patents.
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