Patent Costs Within 30 days after receiving a statement from Stanford, ***** will reimburse Stanford:
Development Costs With respect to activities prior to the Amendment Effective Date, each Party was to pay [*] of the total Direct Development Costs of a Product incurred in accordance with the Development Budget (as defined in the Original Agreement). Notwithstanding anything in this Article 6 of this Agreement or in any other provision of this Agreement to the contrary, with respect to activities on and after the Amendment Effective Date, subject to Sections 3.1.2, Alimera will be solely responsible for, and shall pay one hundred percent (100%) of, all development costs of a Product, including Direct Development Costs. Notwithstanding anything in this Article 6 of this Agreement or in any other provision of this Agreement to the contrary, (i) all payments owing by CDS hereunder with respect to development activities prior to the Amendment Effective Date are hereby deemed fully paid by CDS (or waived, to the extent such waiver may be required), including any Development Payments, Compounded Development Payments, Determined Disputed Costs and Compounded Disputed Costs (as all defined in the Original Agreement), further including any penalties and interest which might have accrued with respect thereto, and further including all CDS payments deferred pursuant to that February 11, 2008 letter agreement sent by CDS and executed by CDS and Alimera regarding deferral of payments under the Original Agreement as of such date; (ii) all payments owing by Alimera hereunder with respect to development activities prior to the Amendment Effective Date are hereby deemed fully paid by Alimera (or waived, to the extent such waiver may be required), including any Development Payments, Compounded Development Payments, Determined Disputed Costs and Compounded Disputed Costs (as all defined in the Original Agreement), and further including any penalties and interest which might have accrued with respect thereto; and (iii) subject to Sections 3.1.1 and 3.1.2, from and after the Amendment Effective Date, CDS will have no liability whatsoever hereunder for any past, present or future development costs, including Direct Development Costs (which includes those incurred before, on and after the Amendment Effective Date), and instead Alimera shall have sole liability therefor.
Patent Expenses Unless agreed otherwise, the Party filing a Patent Application will pay all preparation and filing expenses, prosecution fees, issuance fees, post issuance fees, patent maintenance fees, annuities, interference expenses, and attorneys’ fees for that Patent Application and any resulting Patent(s). If a license to any CRADA Subject Invention is granted to Collaborator, then Collaborator will be responsible for all expenses and fees, past and future, in connection with the preparation, filing, prosecution, and maintenance of any Patent Applications and Patents claiming exclusively licensed CRADA Subject Inventions and will be responsible for a pro-rated share, divided equally among all licensees, of those expenses and fees for non-exclusively licensed CRADA Subject Inventions. Collaborator may waive its exclusive option rights at any time, and incur no subsequent financial obligation for those Patent Application(s) or Patent(s).
Product Claims You acknowledge that Company, not an App Distributor, is responsible for addressing any claims of yours or any third party relating to the Company application or your possession and/or use of the Company application, including, but not limited to: (i) product liability claims; (ii) any claim that the Company application fails to conform to any applicable legal or regulatory requirement; and (iii) claims arising under consumer protection or similar legislation. (5)
Patent Prosecution and Maintenance From and after the date of this Agreement, the provisions of this Section 8 shall control the prosecution of any patent application and maintenance of any patent included within Licensed Patent Rights. TSRI shall (a) direct and control the preparation, filing and prosecution of the United States and foreign patent applications within Licensed Patent Rights (including without limitation any reissues, reexaminations, appeals to appropriate patent offices and/or courts, interferences and foreign oppositions); and (b) maintain the patents issuing therefrom; in each case, using TSRI’s Office of Patent Counsel (“OPC”) or outside patent counsel selected by TSRI and approved by Company in writing, which approval shall not be unreasonably withheld, and consistent with the requirements of this Section 8.1. The parties shall mutually agree in advance, on a Licensed Patent Right-by-Licensed Patent Right basis, whether TSRI’s OPC or independent counsel will be principally responsible for filing, prosecution and maintenance of a Licensed Patent Right, it being understood that if the parties agree that external patent counsel will be principally responsible, TSRI shall have the right, at its sole discretion, to utilize TSRI’s OPC in addition to (i.e., in support of and to direct) such independent counsel’s patent filing, prosecution and maintenance activities. The reasonable and documented fees and expenses with regard to the preparation, filing and prosecution of patent applications and maintenance of patents (including without limitation inter partes proceedings) included within Licensed Patent Rights (“Patent Costs”) shall be paid as set forth below. Company shall have full rights of consultation with TSRI and such outside patent counsel on all matters relating to Licensed Patent Rights. TSRI shall consult, and shall instruct its counsel to consult, with Company as to the preparation, filing, prosecution and maintenance of the Licensed Patent Rights (including, without limitation, any reissues, reexaminations, appeals to appropriate patent offices and/or courts, interferences and foreign oppositions) reasonably prior to any deadline or action with the U.S. Patent & Trademark Office or any foreign patent office, and shall furnish to Company copies of all relevant documents reasonably in advance of such consultation, consider in good faith Company’s comments and suggestions with regard to such preparation, filing, prosecution and/or maintenance (including without limitation any inter partes proceedings) of the patent applications and/or patents within Licensed Patent Rights, and use its reasonable efforts to implement all reasonable and timely requests made by Company; provided, however, that in the event of a disagreement between TSRI and Company on any such patent prosecution or maintenance matters, TSRI shall have final decision-making authority over all such patent matters. Company shall have the right, but not the obligation, to be present at any court or patent office proceedings relating to Licensed Patent Rights. Provided that Company is not in material breach of its obligations under this Agreement, TSRI shall not abandon any patent or patent application within the Licensed Patent Rights without Company’s prior written consent.
Manufacturing Costs Patheon shall be allowed to adjust the Fees: (i) for costs associated with the conversion of Granulations and Components into Drug Product (the “Conversion Costs”) in respect of the Drug Product based on the most recently available final Producers’ Price Index for Pharmaceutical Product as published by the U.S. Bureau of Labor Statistics or any governmental successor thereto (“PPI”) using the procedure set forth in Section 4.3 and (ii) for Component Costs to pass on the actual amount of any increase or decrease in such costs without xxxx-up. For each Contract Year in which Patheon is entitled to adjust the Fees Patheon shall provide Client with written notice of any change in the Fees within 30 days of receipt by Patheon of the Annual Forecast. The Parties agree that the Fees shall not be adjusted more than once per Contract Year, however this limitation shall not include price adjustments under section 4.3 or 4.4. In addition, notwithstanding anything herein to the contrary, Manufacturing Fees associated with Conversion Costs shall not be increased by greater than [***]% per annum in any Contract Year during the Term. There shall be no similar limitation in terms of increases in Component Costs which shall be passed on to Client in an amount equal to the actual increase paid by Patheon without markup.
Development Expenses Novartis shall be solely responsible for the costs and expenses of Developing and commercializing Licensed Products pursuant to the terms of this Agreement, except with respect to Infinity’s research, development and commercialization activities with respect to an Abandoned Profile pursuant to Section 3.3.1 (subject to Section 2.3).
Tenant Improvement Costs The Tenant Improvements’ cost (the “Tenant Improvement Costs”) shall mean and include any and all costs and expenses of the Work, including, without limitation, all of the following:
Joint Improvements Rights and title to the Technology, whether or not patentable, and any patent applications or patents based thereon, which directly relate to and are not severable from Licensor IP and which are improvements thereto by both LICENSOR AND LICENSEE shall be jointly owned intellectual property by LICENSOR AND LICENSEE.
Direct Costs Insert the major cost elements. For each element, consider the application of the paragraph entitled “Costs Requiring Prior Approval” on page 1 of these instructions.
