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.
Appears in 4 contracts
Samples: Collaboration Agreement (pSivida Corp.), Collaboration Agreement (Alimera Sciences Inc), Collaboration Agreement (Alimera Sciences Inc)
Development Costs. With The Parties will share equally all Development Costs for the ADC (which have been set forth in the Clinical Work Plan) with respect to the Development activities prior hereunder. The Parties are obligated to each fund fifty percent (50%) of costs associated with the Amendment Effective DateDevelopment of the ADC up until the final report for the Qualifying Phase I/II Clinical Trial. Notwithstanding the above, each Party was to pay in the event that the manufacturer of the ADC chosen by ADCT is not [**], the Parties agree that ADCT will be solely responsible for the payment of (a) the [**] of [**], and (b) the total Direct [**] of [**]. Also, notwithstanding anything to the contrary in this Agreement, if a certain milestone for [**] of [**] becomes payable to [**] while the Parties are Co-Developing, the Parties agree that ADCT will be responsible for the payment of [**] of such milestone and Genmab will be responsible for the payment of [**] of such milestone. The JSC shall review on a [**] basis the Development Costs against the budget for such expenses in the applicable calendar year. If in the course of such [**] review the JSC determines that the actual amounts incurred for Development Costs are likely to be higher than budgeted, the JSC shall review the reasons for such potential overrun and determine whether such overrun is appropriate. The JSC may, if appropriate, amend the Clinical Work Plan to permit such overrun or to reduce such activities such that no overrun is incurred. If any costs for the Development activities result in a Product incurred budget overrun of the applicable and approved annual joint budget in excess of [**], the JSC shall have the discretion to review such costs and designate them as Development Costs. Where the JSC does not so designate excess Development Costs, any such unapproved excess Joint Development Costs shall be borne by the Party incurring them. However, if the budget overrun is due to a delay or an advance in timing as to the planned activities, which activities are in accordance with the Clinical Work Plan, then such excess Development Budget (as defined in Costs shall be shared equally by the Original Agreement)Parties regardless of which Party has incurred such costs. 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 ADCT agrees that February 11, 2008 letter agreement sent by CDS and executed by CDS and Alimera regarding deferral of payments under the Original Agreement as Spirogen Agreement, if any, shall not be part 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 shall be borne solely by ADCT. Section 7.2 is deleted in its entirety and replaced with the following (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, blacklines showing change 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.original):
Appears in 3 contracts
Samples: Collaboration and License Agreement (ADC Therapeutics SA), Collaboration and License Agreement (ADC Therapeutics SA), Collaboration and License Agreement (ADC Therapeutics SA)
Development Costs. With respect to activities If prior to the Amendment Effective DateCommencement Date Transporter terminates this Agreement under Sections 5(A)(iv) or 5(A)(vi) or Shipper terminates this Agreement under Section 5(D)(iii) , each Party was to then Shipper shall pay [*] Transporter the actual costs reasonably incurred and/or committed by Transporter for the development of the total Direct Project (“Development Costs”). The Development Costs shall include, but shall not be limited to, all costs associated with the following activities: (i) participating in the FERC pre-filing process; (ii) preparing and filing Transporter’s application for a FERC Certificate; (iii) developing, designing, surveying, and performing studies to define the scope of a Product the Project; (iv) developing the design and engineering of the Project Facilities; (v) preparing all drawings, maps, reports, and schedules necessary to be included in Transporter’s application for the FERC Certificate; (vi) contacting and meeting with any and all stakeholders to gain support for, or to appease opposition to, the Project; (vii) preparing, filing, and processing all relevant applications for Transporter Regulatory Authorizations; (viii) identifying the suitability of the property on which the Project Facilities will be constructed and any construction areas that will be needed as part of the Project; and (ix) acquisition of equipment and materials for the construction any portion of the Project Facilities. To the extent that Shipper owes Transporter for Development Costs as provided in this Section 3(E), not later than ninety (90) days following the termination of this Agreement, Transporter shall deliver an invoice (“Invoice”) to Shipper for all Development Costs incurred in accordance with the terms hereof. The Invoice shall set forth all charges and credits (in United States Dollars) summarized by appropriate classifications indicating the nature of the charges. Within thirty (30) days after the receipt of the Invoice, Shipper shall pay Transporter all Development Budget (as defined Costs set forth in the Original AgreementInvoice. To the extent Transporter, using commercially reasonable efforts, is able to mitigate any of the Development Costs during a period of time that extends six (6) months from the date this Precedent Agreement is terminated (“Mitigation”). Notwithstanding anything in this Article 6 of this Agreement or in , Transporter shall provide a credit to Shipper for any other provision of this Agreement such Mitigation which shall include an adjustment to the contrarycosts incurred by Transporter for the Mitigation. If Shipper is required to reimburse Transporter for Development Costs, with respect then Shipper shall have the right, upon at least five (5) business days prior written notice to activities on Transporter, to audit books and after records of Transporter relating to 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 Any such audit shall be conducted during normal business hours and at Shipper’s sole expense. Shipper shall have six (6) months after the date of this Agreement or receipt of an invoice for its share of the Development Costs (but in any other provision of this Agreement to the contrary, event Shipper shall have at least three (i3) 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 months after Transporter closes its books with respect thereto, ) in which to complete such an audit 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 submit claims 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 thereforthis provision.
Appears in 2 contracts
Samples: Consent for Execution of Precedent Agreement (Cheniere Energy Inc), Consent for Execution of Precedent Agreement (Cheniere Corpus Christi Holdings, LLC)
Development Costs. With (a) During the Early Clinical Development Term, SGI will reimburse Unum for [***] of all Development Costs for all Development Candidates actually incurred for the Territory pursuant to the Early Clinical Development Plan, in accordance with Section 11.5, subject to the following sentence. Notwithstanding the amounts allocated to Development activities in the Shared Territory in the applicable Early Clinical Development Plan budget, for any calendar year, Unum will only be permitted to recover Development Costs with respect to Development activities prior that have been allocated to Unum under the Amendment Effective Date, each Party was Early Clinical Development Plan and related budget in excess of the amount allocated therein (i) by up to pay [***] of the total Direct amount so allocated, or (ii) with the unanimous approval of the JDC, which approval may be granted either in advance of such costs being incurred or retroactively. For clarity, during the Early Clinical Development Term, Unum will not be required to incur any Development Costs for any Development Candidates for which SGI will not reimburse Unum, and SGI will not be required to reimburse Unum for any Development Costs not approved by SGI as and to the extent required under this Agreement.
(b) Subject to Section 6.2(a)(iv), during the Late Clinical Development Term, SGI will be responsible for [***] of a all Development Costs for each Development Candidate and associated Product incurred in the Licensed Territory pursuant to the Late Clinical Development Plan. In the event that Unum performs any Development activities for which SGI is solely responsible for the costs and expenses hereunder, Unum will invoice SGI for such expenses and SGI will reimburse Unum for such costs and expenses in accordance with Section 11.5.
(c) During the Late Clinical Development Budget (as defined Term, Unum will be responsible [***] and SGI will be responsible for [***] of all Development Costs for each Development Candidate and associated Product actually incurred for the Shared Territory pursuant to the Late Clinical Development Plan, subject to the following sentence. Notwithstanding the amounts allocated to Development activities in the Original Agreement). Notwithstanding anything Shared Territory in this Article 6 of this Agreement or in the applicable Late Clinical Development Plan budget, for any other provision of this Agreement calendar year, each Party will only be permitted to the contrary, recover Development Costs with respect to Development activities on that have been allocated to such Party under the Late Clinical Development Plan and after related budget in excess of 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, amount allocated therein (i) all payments owing by CDS hereunder with respect up to development activities prior to [***] of the Amendment Effective Date are hereby deemed fully paid by CDS (amount so allocated, 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 the unanimous approval of the JDC, which approval may be granted either in advance of such costs being incurred or retroactively. The Parties will reconcile the Development Costs they have actually incurred to development activities prior reflect the foregoing allocation of Development Costs according to the Amendment Effective Date are hereby deemed fully paid by Alimera (procedures in Section 11.5 or waivedSection 11.6, 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 thereforapplicable.
Appears in 2 contracts
Samples: Collaboration Agreement (Unum Therapeutics, Inc.), Collaboration Agreement (Unum Therapeutics, Inc.)
Development Costs. With respect 7.6.1. Subject to activities prior to the Amendment Effective Datethis Section 7.6, each Party was shall be responsible for and shall reimburse the other Party, as applicable, for Development Costs reasonably incurred after the Effective Date in connection with the performance of Development activities in accordance with the cost-sharing principles set forth below and the Development Plan, unless otherwise agreed by the Parties and set forth in the Development Plan. To the extent FTE efforts are included in Development Costs and reimbursable by the other Party pursuant hereto, each Party shall record and account for such FTE efforts with respect to pay each Licensed Product, and each Party shall report such FTE efforts to the DRC on a quarterly basis. Each Party shall calculate and maintain records of FTE effort incurred by it consistent with past practice and in the same manner as used for other products developed by such Party, unless agreed by the Parties in writing. The Parties shall share Development Costs according to the following principles:
(i) Sanofi shall be responsible for [**], and Lexicon shall be responsible for [**] of the total Direct Development Costs of a Product incurred in connection with T2DM Development under and 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 Plan, which Development Costs are incurred prior to the contrarydate that is the third (3rd) anniversary of the Effective Date, with respect (the “Cost Sharing Trigger Point”); provided Development Costs corresponding to Development activities for T2DM Development which were, due to any action or inaction by Lexicon, incurred on and after instead of prior to the Amendment Effective DateCost-Sharing Trigger Point shall be allocated between the Parties in accordance with the allocation for Development Costs for T2DM Development in effect prior to the Cost-Sharing Trigger Point; provided further, subject to Sections 3.1.2, Alimera will be solely responsible forthat Lexicon’s share of Development Costs under this Section 7.6.1(i) shall not exceed one hundred million Dollars ($100,000,000) in the aggregate, and Sanofi shall pay be responsible for any Development Costs covered by this clause (i) in excess of such amount;
(ii) Sanofi shall be responsible for one hundred percent (100%) ofof Development Costs in connection with T2DM Development under and in accordance with the Development Plan, all development costs which Development Costs are incurred after the Cost Sharing Trigger Point under the Development Plan;
(iii) Sanofi shall be responsible for [**] of Development Costs incurred under and in accordance with the Development Plan that are not specifically attributable to T2DM Development or T1DM Development;
(iv) Lexicon shall be responsible for one hundred percent (100%) of Development Costs incurred under and in accordance with the Development Plan in connection with T1DM Development (where for clarity, Development Costs incurred for any activity specified in the Development Plan as T1DM Development shall be borne by Lexicon); and
(v) For clarity, any payments due under the T1DM Funding Agreements shall not be included in Development Costs or Commercialization Costs and shall be solely borne by Lexicon. provided, that, in each case of clauses (i) through (iv) above, a Product, including Direct Party shall not be responsible for Development Costs. Notwithstanding anything in this Article 6 Costs incurred by either Party due to a breach of this Agreement by, or the negligence or willful misconduct of, the other Party or any of its Affiliates (the “At-fault Party”), including, for example, delay in any other provision shipping a bulk batch of Licensed Compound or Licensed Product, which such Development Costs shall be borne by the At-fault Party.
7.6.2. Any Development Costs in excess of the Development Costs for a given activity budgeted in the Development Plan shall be borne by the incurring Party and shall be excluded from Development Costs hereunder unless such excess was due to breach of this Agreement by, or the negligence or willful misconduct of, the other Party or any of its Affiliates, in which case, such excess Development Costs shall be borne by the At-fault Party.
7.6.3. For so long as Development Costs are reimbursable by a Party pursuant hereto, the other Party shall report to the contraryreimbursing Party, within [**] after the end of each Calendar Quarter (iand within [**] after receipt of each such report, the Parties shall reimburse one another, as needed, for) all payments owing its respective Development Costs in order to achieve the cost sharing allocation contemplated by CDS hereunder with respect to development activities prior to this Section 7.6. Each such report shall (a) allocate the Amendment Effective Date are hereby deemed fully paid by CDS (or waived, Development Costs to the extent possible to a specific Development activity under the Development Plan, (b) specify in reasonable detail all amounts included in Development Costs during such waiver may be requiredCalendar Quarter (broken down by activity), including (c) if requested by the other Party, include copies of any Development Payments, Compounded Development Payments, Determined Disputed Costs and Compounded Disputed Costs (as all defined in the Original Agreement), further including invoices or other supporting documentation for any penalties and interest which might have accrued with respect thereto, and further including all CDS payments deferred pursuant to a Third Party 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 individually exceed [**] (or waivedsuch other amount approved by the JSC or DRC, 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; applicable) and (iiid) subject enable the other Party to Sections 3.1.1 compare the reported costs against the Development Plan on both a quarterly basis and 3.1.2, from and after a cumulative basis for each activity. The Parties shall seek to resolve any questions related to such reports within [**] following receipt by 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 other Party of the Amendment Effective Date), and instead Alimera shall have sole liability thereforreporting Party’s report hereunder.
Appears in 2 contracts
Samples: Collaboration and License Agreement (Lexicon Pharmaceuticals, Inc.), Collaboration and License Agreement (Lexicon Pharmaceuticals, Inc.)
Development Costs. With respect to Except as provided in Section 4.3, PRAECIS shall pay seventy-five percent (75%), and Synthelabo shall pay twenty-five percent (25%), of all Development Costs incurred in carrying out the Core Development Plan. The foregoing cost sharing provisions shall also apply if PRAECIS enters into an agreement with a Third Party under which such Third Party shall undertake PRAECIS' development activities prior pursuant to the Amendment Effective DateCore Development Plan, each Party was unless PRAECIS and Synthelabo shall agree otherwise. Synthelabo shall pay all Development Costs which are incurred in carrying out the Supplemental Development Plan, provided that PRAECIS shall reimburse Synthelabo for seventy-five percent (75%) of such Development Costs to pay [*] the extent the results of the total Direct Development Phase activities in respect of which such Development Costs were incurred are used to seek or obtain Registration Approvals or Reimbursement Approvals in the United States. If (i) PRAECIS or its licensee or sublicensee wishes to use both outside of a Product the Territory and outside of the United States the results of the Supplemental Development Studies obtained by Synthelabo in carrying out the Supplemental Development Plan and (ii) PRAECIS is not required hereunder to reimburse Synthelabo 75% of the Development Costs incurred in accordance connection with the such Supplemental Development Budget (as defined Studies, then PRAECIS and Synthelabo shall meet to negotiate in the Original Agreement). Notwithstanding anything in this Article 6 good faith an equitable sharing 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 such Development Costs. Notwithstanding anything in this Article 6 of this Agreement or in any other provision of this Agreement Anything herein to the contrarycontrary notwithstanding, (i) all payments owing each of Synthelabo and PRAECIS shall have full and complete access to and use of the safety data of the other regarding each Licensed Product, and each may use the safety data of the other for Advertising and Promotion, in each case without any cost or reimbursement therefor and (ii) regulatory submission, registration fees and maintenance fees in the Territory shall be paid by CDS hereunder with respect Synthelabo, and registration fees and maintenance fees 40 outside the Territory shall be paid by PRAECIS. If a party is claiming reimbursement pursuant to development activities prior this Section 4.5, then within forty-five (45) days after the end of a calendar quarter during which the Development Costs for which reimbursement is being claimed were incurred, a party will submit to the Amendment Effective Date are hereby deemed fully other a statement (each a "Development Cost Statement") itemizing in reasonable detail such Development Costs and setting forth the total amount, if any, of such Development Costs to be reimbursed by the other party pursuant to this Section 4.5. Such reimbursement amounts shall be paid by CDS within twenty (or waived20) days after receipt of a Development Cost Statement, except to the extent such waiver may be required)Development Cost Statement is being disputed in good faith. Except as otherwise provided herein, including any each party shall assume full responsibility for its own 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 thereforCosts.
Appears in 2 contracts
Samples: License Agreement (Praecis Pharmaceuticals Inc), License Agreement (Praecis Pharmaceuticals Inc)
Development Costs. Except as otherwise set forth in this Section 3.4, BDSI shall be responsible for all costs and expenses incurred by it in connection with its performance of Clinical Trials of Product in the U.S. pursuant to the Development Plan hereunder, which shall only include any costs associated with the conduct of the *** for any of the foregoing, and BDSI’s internal operating costs with respect to any of the foregoing, such as costs of personnel and overhead therefor. “Development Costs” means ***. With respect to activities prior the ***, BDSI shall be responsible for the first $*** in Development Costs incurred by BDSI in connection therewith, Endo shall be responsible for the next $*** in Development Costs incurred by BDSI in connection therewith, and the Parties shall share equally in all Development Costs incurred by BDSI in connection therewith in excess of $*** (and, within *** of receiving any invoice from BDSI for any portion of Endo’s share of such Development Costs pursuant to the Amendment Effective Dateforegoing, 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 AgreementEndo shall reimburse BDSI for such amount). Notwithstanding anything in this Article 6 of this Agreement or in any other provision of this Agreement BDSI shall have the right, upon written notice to the contrary, Endo with respect to activities on and after the Amendment Effective Dateany portion of Development Costs to be borne by BDSI hereunder, subject to Sections 3.1.2cause Endo to pay or reimburse BDSI such costs (any portion thereof to be paid by Endo within *** of an invoice therefor from BDSI), Alimera will ***. Endo shall also 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, for (i) all payments owing by CDS costs and expenses incurred in connection with the Post-Approval Development Activities, (ii) all Development Costs (and other costs) incurred in connection with the development of Product outside of the U.S. or any Clinical Trials other than the ***, and (iii) all costs associated with Post-Approval Regulatory Submissions as set forth in Section 4.2. For the purpose of clarity, except as otherwise specified in this Agreement, each Party shall be responsible for their own internal operating costs, such as personnel and overhead, in performing their obligations 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.development. ***
Appears in 1 contract
Samples: License and Development Agreement (Biodelivery Sciences International Inc)
Development Costs. With respect to activities prior Subject to the Amendment Effective Dateexclusions set forth in Section 1.4.4.3 below, each Party was all commercially reasonable costs, fees and expenses incurred by Landlord to pay [*] the extent specifically arising out of, and limited to, the design, development and construction of the total Direct Landlord's Xxxx 3 Work (including associated common areas, walkways, parking areas, dirt removal, landscaping, and related improvements), and of obtaining all permits, approvals, authorizations and licenses required to construct the Landlord's Xxxx 3 Work, and any BTS FF&E Costs incurred by Landlord or Tenant in accordance with Section 1.4.4.2.8, below, as Project Costs (collectively, the "Development Costs"); provided, however, that to the extent that any of the foregoing items of Landlord's Xxxx 3 Work of the Base, Shell and Core (as defined in the Xxxx 3 Work Letter) are SMB Cost Items (as defined in Section 1.6.1 below), Tenant may elect, to the extent that Landlord confirms that the costs of acquisition of materials, labor and other construction costs of such SMB Cost Items are reasonably severable from the construction costs of the remainder of the Landlord's Xxxx 3 Work of the Base, Shell and Core (which confirmation shall not be unreasonably withheld), to designate some or all of the costs of such SMB Cost Items as SMB Costs, in lieu of Development Costs, and to the extent that Tenant elects to designate such SMB Cost Items as SMB Costs, (a) the cost of such SMB Cost Items shall be expressly identified as such in the BB Construction Contract (as defined in the Xxxx 3 Work Letter), and paid by Tenant as if they were included the BTS Over-Allowance Amount, regardless of whether the BTS Project Cost Limit is actually exceeded, and (b) such Xxxx 3 SMB Cost Items designated and paid for by Tenant as SMB Costs shall be excluded from Development Costs (and from the calculation of a Product any related Project Costs) for the purposes of determining the Must-Take Space 2 Base Rent pursuant to this Section 1.4.4. Except for the deemed Capital Carry Costs and Development Fee set forth in Sections 1.4.4.2.3 and 1.4.4.2.7, Development Costs shall be limited to Landlord’s actual out-of-pocket expenses incurred in accordance with the terms and conditions of the Xxxx 3 Work Letter. A preliminary budget of Development Budget (Costs is attached hereto as defined in the Original Agreement). Notwithstanding anything in this Article 6 of this Agreement or in any other provision of this Agreement Exhibit G. Subject to the contraryforegoing, 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 shall be defined as the Amendment Effective Date), and instead Alimera shall have sole liability therefor.following:
Appears in 1 contract
Samples: Lease (Nuvasive Inc)
Development Costs. With Each of the Initial Projects shall be reviewed prior to any expenditure by the Joint Venture Management Committee. The Parties acknowledge that NWP has incurred development costs with respect to activities the Initial Projects prior to July 31, 1996 of $2.5 million. Subject to the approval requirements for expenditures provided below, in consideration of DBP's receiving a 50% equity interest in the Initial Projects DBP shall pay with respect to the Initial Projects specified on Exhibit A hereto up to $2.5 million (the "Initial Funding Commitment") to equal the amount of development costs for which NWP has received credit pursuant to the first sentence of this paragraph; provided, however, (i) that the Initial Funding Commitment shall be reduced by the amount of unexpended development costs to be funded by DBP with respect to Initial Projects which are abandoned by the Management Committee and (ii) in no event shall the Initial Funding Commitment be less than $500,000 (including Development Costs of approximately $130,000 incurred prior by DBP prior to the Amendment Effective Date, each Party was to pay [*] date of this Agreement). Within five days of the total Direct Development Costs execution of a Product incurred this Agreement, DBP shall deposit into an escrow account $400,000 to be earmarked exclusively for the development of the Texas Project. The Initial Funding Commitment shall be satisfied by the payment by DBP of costs related to Projects in accordance with the Development Budget (Project budget. Except as defined DBP shall determine in the Original its sole discretion, prior to any funding of a Project pursuant to this Agreement), NWP shall execute bills of sale and such instruments of transfer as DBP shall reasonably request so as to effect DBP's purchase of a 50% interest in each such Project. Notwithstanding anything in this Article 6 of this Agreement or in any other provision of this Agreement to the contrary, Except as set above with respect to activities DBP's commitment of development costs with respect to the Initial Projects, the Parties shall share all project development costs equally, with NWP being responsible for the development costs which will be incurred prior to acceptance of a Project by the Joint Venture, DBP being responsible for the next portion of development costs equal to NWP's initial contribution and the Parties being responsible for the remaining development costs on a 50/50 basis. Development costs shall only be incurred at the direction of the Management Committee and after until a Party declines, in its sole discretion, to participate in the Amendment Effective Datedevelopment of such project, or a Party or the Joint Venture or a Project Entity abandons or transfers its interest in a Project, or a Party is otherwise required to discontinue its participation in a Project. Development costs include out-of-pocket, third-party expenses reasonably incurred by the Parties in furtherance of development of a Project as well as the cost associated with employees and consultants of the Parties who perform work to develop a power project, as provided below. In no event shall the reimbursable costs for employees and consultants of a Party or an affiliate thereof be credited in excess of an hourly rate which exceeds 1.4 times the hourly equivalent wage in the case of an employee or 1.1 times the hourly fee of a consultant retained by such Party, in each case for the actual time period involved by such staff in Joint Venture development activities. Each Party shall be required to submit detailed time sheets setting forth the tasks performed by the employees and/or consultants in respect of Joint Venture activities. It is anticipated that NWP employees and consultants will perform a majority of the development activities. DBP shall have the ability, however, to dedicate up to one full-time equivalent employee to Joint Venture activities, subject to Sections 3.1.2, Alimera will be solely responsible for, agreement by the Parties as appropriate concerning time commitment 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 cost reimbursement arrangements with respect thereto. Each Party shall submit bills (and provide all reasonably requested supporting documentation) for development costs incurred after July 31, 1996 on a monthly basis 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 each Party's share of such date; (ii) all payments owing by Alimera hereunder with respect costs shall be payable within 30 days of submission of such bills. Semiannually, the Parties shall review and reconcile any development costs incurred hereunder. Verified development costs shall be recovered at project financial closing unless converted to development activities prior to the Amendment Effective Date are hereby deemed fully paid by Alimera (equity 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 subordinated debt 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 thereforprojects.
Appears in 1 contract
Samples: Joint Venture Agreement (New World Power Corporation)
Development Costs. With respect The Parties shall each be responsible for their respective share, as defined in this Section 4.5, of all Joint Development Costs. Mundipharma shall be responsible for the “Mundipharma Share” of Joint Development Costs, which share shall initially be forty percent (40%) of the Joint Development Costs and shall become fifty percent (50%) of the Joint Development Costs (the “50/50 Threshold”) (a) in the calendar quarter after Mundipharma receives Conditional Approval or (b) if such Conditional Approval is not obtained, the later of (i) the calendar quarter of the first Drug Approval in the EU of the Product in the Lead Indication or First Line PTCL, and (ii) the first calendar quarter in which the Development Cost Differential equals or exceeds fifteen million Dollars ($15,000,000); provided, if the Development Cost Differential does not equal or exceed fifteen million Dollars ($15,000,000) by December 31, 2019, then Allos shall be required to activities prior remit the difference between fifteen million Dollars ($15,000,000) and the Development Cost Differential as of such date to Mundipharma on or before January 31, 2020 and thereafter the Mundipharma Share shall be fifty percent (50%). For purposes of this Section 4.5, the “Development Cost Differential” means the difference between (A) the cumulative amount of Joint Development Costs borne by Mundipharma (whether as reimbursement to Allos pursuant to Section 7.2(a) or as Joint Development Costs directly incurred by Mundipharma to the Amendment Effective Date, each Party was to pay [*] of the total Direct extent that such Joint Development Costs of a Product incurred in accordance exceed Allos’ reimbursement to Mundipharma pursuant to Section 7.2(b)), together with the Development Budget any Joint Manufacturing Costs (as defined in the Original Supply Agreement) borne by MMCO pursuant to the Supply Agreement, and (B) the cumulative amount of Joint Development Costs that Mundipharma would have borne if Mundipharma had been responsible for fifty percent (50%) of Joint Development Costs (rather than forty percent (40%) of Joint Development Costs). Notwithstanding anything , together with any Joint Manufacturing Costs (as defined in the Supply Agreement) that MMCO would have borne pursuant to the Supply Agreement if MMCO had been responsible for fifty percent (50%) (rather than forty percent (40%)) of Joint Manufacturing Costs under the Supply [ * ] = Certain confidential information contained in this Article 6 document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 24b-2 of this Agreement or in any the Securities Exchange Act of 1934, as amended. Agreement. Allos shall be responsible for the Allos Share of Joint Development Costs as well as for all costs and expenses of the Allos Studies. The Party conducting an Incremental Study shall be solely responsible for all costs and expenses of such Incremental Study, unless the other provision of this Agreement to the contrary, Party exercises its Opt-In Right 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 such study 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 accordance 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 requiredSection 4.4(c)(v), 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.
Appears in 1 contract
Samples: License, Development and Commercialization Agreement (Allos Therapeutics Inc)
Development Costs. With Medivation shall be responsible for fifty percent (50%) and Astellas shall be responsible for fifty percent (50%) of all Joint Development Costs, except with respect to activities prior costs of Non-Clinical Studies and Clinical Trials (including the costs of drug product or comparator drug for use therein) and the costs of CMC Activities (a) contemplated in the Joint Development Plan and (b) reasonably considered to be required for receipt of Regulatory Approvals for Products in the Amendment Effective DateShared Territory and either or both of the EU and Japan, each Party was to pay for which Medivation shall be responsible for one-third (1/3) and Astellas shall be responsible for two-thirds (2/3). [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the securities and exchange commission pursuant to rule 24b-2 of the total Direct Development Costs securities exchange act of a Product incurred in accordance with the Development Budget (1934, as defined in the Original Agreement)amended. Notwithstanding anything in this Article 6 of this Agreement or in any other provision of this Agreement Prior to the contraryinitiation of any Non-Clinical Study, Clinical Trial or CMC Activity commencing after the Effective Date supporting Development of Products with respect to activities on the Shared Territory and after either or both of the Amendment Effective DateEU and Japan, subject the Parties shall agree whether the costs of such study or activity are to Sections 3.1.2, Alimera will be solely shared equally by the Parties or allocated pursuant to clause (b) above. Astellas shall be responsible for, and shall pay for one hundred percent (100%) of, of all development Development Costs for the Licensed Territory if such costs of a Product, including Direct are not included in Joint Development Costs. The allocation of costs for the Non-Clinical Studies and Clinical Trials contained in the Initial Joint Development Plan shall be as set forth therein. Notwithstanding anything the amounts allocated to Development activities in this Article 6 of this Agreement or in the applicable Joint Development Plan, for any other provision of this Agreement calendar year, Astellas and Medivation shall each be permitted to the contrary, (i) all payments owing by CDS hereunder recover Joint Development Costs with respect to development such Party’s Development activities prior for such year covered in the Joint Development Budget in excess of the amount allocated therein (x) by up to [*] of the Amendment Effective Date are hereby deemed fully paid by CDS (or waivedamount so allocated, but solely to the extent such waiver overage was outside the reasonable control of the applicable Party and was not attributable to a failure by the applicable Party to use commercially reasonable efforts to adequately supervise any Third Party performing such activities or (y) with the unanimous approval of the JDC, which approval may be required), including any Development Payments, Compounded Development Payments, Determined Disputed Costs and Compounded Disputed Costs (as all defined granted either 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 advance of such date; (ii) all payments owing by Alimera hereunder with respect costs being incurred or retroactively. The Parties shall reconcile the Joint Development Costs they have incurred to development activities prior reflect the foregoing allocation of Joint Development Costs according to the Amendment Effective Date are hereby deemed fully paid by Alimera (procedures in Section 9.2 or waivedSection 9.3, 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 thereforapplicable.
Appears in 1 contract
Development Costs. With (a) The responsibility for payment of the Development Costs incurred during the Term will be shared between AEVI and KKC as set forth below:
(i) with respect to activities prior to the Amendment Effective Date, each Party was to pay [*] Development of the total Direct initial indication for the Licensed Product in the Field in the Territory and in the European Union, the Parties will equally split the Development Costs of a Product incurred in accordance with a JSC-approved Development Plan up to aggregate Development Costs of (***); provided, that the Parties acknowledge that the initial Development Plan currently budgets (***); and further provided, for clarity, that increasing the Development Budget (as defined budget for the initial indication in the Original Agreement). Notwithstanding anything Field in this the Territory and the European Union requires compliance with the JDC, JSC, escalation and decision-making process set forth in Article 6 of this Agreement or 3;
(ii) except for Development Costs incurred for Phase 4 Clinical Trials, if Development Costs for the initial indication in the Territory and the European Union exceeds (***) for any other provision of this Agreement to the contraryreason, with respect to activities on and after the Amendment Effective Date, subject to Sections 3.1.2, Alimera then AEVI will be solely responsible for, and shall pay one hundred percent to fund such excess;
(100%iii) of, all development costs the Parties will equally split the Development Costs incurred for Phase 4 Clinical Trials; and
(iv) the allocation 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 Costs between the contrary, (i) all payments owing by CDS hereunder Parties with respect to development activities prior to Development of the Amendment Effective Date are hereby deemed fully paid by CDS (or waived, to Licensed Product for indications beyond the extent such waiver may be required), including any Development Payments, Compounded Development Payments, Determined Disputed Costs and Compounded Disputed Costs (as all defined initial indication in the Original Agreement), further including any penalties Field in the Territory and interest which might have accrued with respect thereto, and further including all CDS payments deferred pursuant to that February 11, 2008 letter the European Union will be a matter for written agreement sent by CDS and executed by CDS and Alimera regarding deferral of payments under the Original Agreement as Parties if the JSC approves Development of such date; additional indication(s).
(iib) 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 Development Costs will not include 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 Manufacturing-related development costs, including Direct but not limited to the process and analytical method developments, the comparability studies, stability program, process characterization and validation, method qualifications and validations, or the cost incurred in connection with the Manufacture of clinical supplies of Licensed Product for Development in the Territory and the European Union, which costs will be borne solely by AEVI pursuant to Section 4.3.3. All payments made by a Party to a Third Party in connection with the performance of its activities under the applicable Development Plan will be charged as Development Costs (which includes those incurred beforeat such Party’s actual Out-of-Pocket Costs. For the avoidance of doubt, on and after the Amendment Effective Date), and instead Alimera shall have sole liability thereforcost for Phase 4 Clinical Trial conducted in Territory and/or European Union will be included in Development Costs.
Appears in 1 contract
Samples: Clinical Development and Option Agreement (Cerecor Inc.)
Development Costs. With Metroplex shall pay or advance to the Company all of the Development Costs incurred for developing each parcel of the Joint Venture Property and the Cable Property, to the extent provided in Section 8(c) of the Joint Contribution Agreement, until such parcel is subject to a binding commitment to be sold or leased (to a primary tenant) by the Company (a "Commitment"). All Development Costs paid or advanced to the Company by Metroplex with respect to activities prior a parcel before it is subject to a Commitment shall be promptly reported to the Amendment Effective DateCompany and, each Party was if such Development Costs (when added to pay [*] of previously reported and approved Development Costs) are within the total Direct amount of expenditures contemplated for the relevant line item category of expenditures in the relevant Development Budget, or are otherwise approved in writing by GCN, they shall be accounted for by the Company as Additional Capital Contributions by Metroplex; provided, however, that no such contributions shall affect the Percentage Interest or Voting Interest of Metroplex in the Company. In all such reports and requests for approval, Internal Development Costs shall be identified by Metroplex as separate line item components of a Product incurred in accordance with the its Development Budget (as defined in the Original Agreement)Costs. Notwithstanding anything in this Article 6 any contrary provision of this Agreement or the Joint Contribution Agreement, Metroplex shall not be required to incur any Development Costs that either (i) are not included in any other provision of this Agreement to the contrarysuch a Development Budget; or (ii) would generally be incurred, under commonly accepted practices for similar developments in Clarx Xxxnty, Nevada, with respect to activities on and a parcel after the Amendment Effective Date, it is subject to Sections 3.1.2a Commitment. Each Member may contribute from time to time as an Additional Capital Contribution such additional money or other property as the Appointing Members may agree in writing; provided, Alimera will however, that any Additional Capital Contribution of property (other than money) made pursuant to this paragraph shall be solely responsible for, subject to the terms and shall pay one hundred percent (100%) of, all development costs provisions of a Product, including Direct Development Costs. Notwithstanding anything in this Article 6 of this Contribution Agreement or in any other provision of this Agreement to approved by the contrary, (i) all payments owing by CDS hereunder with respect to development activities prior to Board and 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 Appointing Members and executed by CDS the contributing Member and Alimera regarding deferral of payments under the Original Agreement as a Manager prior to delivery of such date; property. Except as otherwise provided in the paragraphs (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 requireda), (b) and (c) of this Section 6.3, if Additional Capital Contributions are not made equally by all Members, the Percentage Interests and Capital Accounts of each Member shall be equitably adjusted to account for any non-pro-rata Additional Capital Contributions on terms that shall be set forth in a Contribution Agreement approved by the Board and Members holding at least two-thirds of the Voting Interests (including at least any Development Payments, Compounded Development Payments, Determined Disputed Costs and Compounded Disputed Costs (as all defined in the Original AgreementMember whose Interest would be adversely affected), and further including any penalties and interest signed as provided in the preceding paragraph, which might have accrued with respect thereto; and (iii) subject agreement shall serve as an amendment to Sections 3.1.1 and 3.1.2Section 5.2. Any such agreement may also equitably adjust the Members' Voting Interests. Additional Membership Interests may be granted only as permitted by Section 5.3. If an additional Membership Interest is granted, 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 Section 5.2 shall have sole liability thereforbe appropriately amended.
Appears in 1 contract
Development Costs. With (a) All Development Costs incurred by or on behalf of the Parties in researching and Developing the Array Compounds and/or Products shall be borne as follows:
(i) Novartis shall be responsible for all Development Costs incurred by or on behalf of either Party with respect to activities Array Compounds or the Products, in accordance with Development Plan, other than the Array Development Costs (as defined below) which shall be borne by Array to the extent provided below. Notwithstanding the foregoing, any Development Costs incurred by Array prior to July 1, 2010 shall be borne by Array and such costs shall not be included within the Amendment Effective Date, each Party was to pay Array Development Costs.
(ii) Array shall be responsible for [***] of the total Direct all Development Costs incurred after July 1, 2010 by or on behalf of a Product either Party (including Development Costs incurred during [***], subject to the next sentence and (iii) below) with respect to Array Compounds or the Products, in accordance with Development Plan (“Array Development Costs”); provided, that the aggregate Array Development Budget Costs shall not exceed [***] for all Products and Array Compounds combined (the “Array Aggregate Cap”). Array Development Costs with respect to [***]. Promptly following such [***], Array’s obligation to pay Array Development Costs will [***]. Novartis shall deliver to Array an invoice for the Accrued Array Development Costs in the form attached as Exhibit B and Array shall pay Novartis all [***], subject to the Array Annual Cap (as defined in below) and the Original Agreement). Notwithstanding anything in this Article 6 Array Aggregate Cap within sixty (60) days from the date of this Agreement or in any other provision receipt by Array of this Agreement such invoice.
(iii) Subject to the contraryArray Aggregate Cap, with respect Array’s obligation to activities on and after pay the Amendment Effective DateArray Development Costs, subject to Sections 3.1.2including Accrued Array Development Costs, Alimera will be solely responsible for, shall [***] and shall pay one hundred percent be capped on a yearly basis as follows (100%) ofthe cap for each Contract Year being referred to as the “Array Annual Cap”): provided, 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 waivedthat, to the extent such waiver may be required), that the Array Development Costs (including any [***]) for any Contract Year exceed the amount of the Array Annual Cap for such year, the amount of such excess will be deemed Accrued Array Development PaymentsCosts for such Contract Year and accrued and added to the amount payable in the following Contract Year, Compounded subject to the Array Aggregate Cap and the Array Annual Cap for such following Contract Year (including in the [***] Contract Year of the term of this Agreement and beyond if there are any unpaid amounts in the [***] Contract Year of the term of this Agreement) until all such unpaid amounts have been fully paid or until the Array Aggregate Cap is reached, whichever occurs first, provided that Array’s payment obligation in [***] and each subsequent Contract Year shall in no event exceed [***] per Contract Year. In no event shall Array be obligated to make payments to Novartis in a Contact Year for Array 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 Accrued Array Development Costs) in excess of payments under the Original Agreement Array Annual Cap for such Contract Year.
(b) For so long as of such date; (ii) all payments owing by Alimera hereunder Array has or is accruing payment obligations 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 Array Development Costs (which, for the avoidance of doubt, includes [***]), each Party shall prepare and deliver to the other Party (and during any period thereafter in which includes those Array Development Activities are continuing under the Development Plan, Array shall prepare and deliver to Novartis) preliminary quarterly written reports in a form approved by the JDC setting forth all Development Costs (i.e., all FTE Costs and all Out-of-Pocket Costs) incurred beforein the performance of all Development activities, as set forth in the Development Plan in the applicable Calendar Quarter by such Party on and an activity-by-activity basis. Such preliminary quarterly reports shall be submitted within twenty-one (21) days after the Amendment Effective Date), end of the relevant Calendar Quarter. Each Party shall then have the opportunity to inquire to the other Party with respected to any items included in the preliminary quarterly report so provided and instead Alimera shall have sole liability therefor.to request additional information related to Development Costs contained in the other Party’s preliminary quarterly
Appears in 1 contract
Development Costs. With respect to activities prior Subject 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 other provisions of this Agreement Agreement, Owners shall be responsible for the payment, without deduction or in any other provision setoff (except as otherwise expressly set forth herein), of this Agreement all costs incurred to develop and construct 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 Project (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”) including, without limitation, (i) all payments owing by CDS hereunder amounts payable under any Construction Contract, architect agreement or other contract or agreement respecting the design and construction of the Project entered into in accordance with respect to development activities prior to the Amendment Effective Date are hereby deemed fully paid by CDS (or waivedterms of this Agreement and the Related Documents, 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 taxes payable with respect to development activities prior to the Amendment Effective Date are hereby deemed fully paid by Alimera Project (or waivedother than income, to the extent such waiver may be requirednet profits and similar taxes), 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) the premiums for all insurance required or permitted hereunder and carried by or on behalf of Developer with respect to the Project, (iv) all permit and approval fees incurred with respect to the Project, (v) the Development Fee, (vi) the Bonding Costs, and (vii) all other costs and expenses incurred by Developer in the performance of its obligations under this Agreement. Notwithstanding the foregoing (A) Owners shall not be required to pay for the aggregate amount of Guaranty Cost Items in respect of the Base Project Improvements and Hotel Furnishings which exceed the Base LEGAL\19062995\17 Project Guaranteed Maximum Development Price, and (B) Office Owner shall not be required to pay for the aggregate amount of Guaranty Cost Items in respect of the Tenant Improvements which, when added to amounts expended by Major Tenants (without duplication) for Guaranty Cost Items in respect of the Tenant Improvements, exceed the Tenant Improvements Guaranteed Maximum Development Price. Office Owner shall cause the Major Tenant to advance and pay pursuant to the terms of the Work Letter, subject to Sections 3.1.1 the rights of Major Tenant to object thereto and 3.1.2withhold payment under the Work Letter, from all costs and after payments which are the Amendment Effective DateMajor Tenant’s responsibility under the Work Letter. Notwithstanding anything to the contrary contained in this Agreement, CDS will have Owners shall not be deemed to be in default with respect to a monetary obligation under this Agreement so long as no liability whatsoever hereunder for any pastFunding Default exists. Title to all work, present or future development costs, including Direct Development Costs (which includes those incurred before, on and after the Amendment Effective Date)materials, and instead Alimera equipment installed in or about the Project shall have sole liability pass to the Owner(s) and/or Major Tenant, as applicable, upon the applicable party’s receipt of payment therefor, free and clear of any liens, claims, security interests or encumbrances.
Appears in 1 contract
Samples: Development Agreement (Liberty Property Limited Partnership)
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 GNE shall be solely responsible for, and shall pay one hundred percent (100%) ofreimburse SGEN on a [***] basis for, all development costs and expenses actually incurred by or on behalf of a ProductSGEN in connection with SGEN’s performance of its Development responsibilities specified in the Development Plan and agreed to by SGEN pursuant to Section 4.1(b). In particular, including Direct GNE shall reimburse SGEN for such costs and expenses as follows: (a) [***]; and (b) [***]. For clarity, Development Costsactivities are exclusive of any Other SGEN Research activities and [***], at which time GNE shall reimburse SGEN for all costs and expenses actually incurred by or on behalf of SGEN since the Execution Date in connection with SGEN’s performance of such [***]. Notwithstanding anything in In determining [***] Certain information on this Article 6 of this Agreement or in any other provision of this Agreement to page has been omitted and filed separately with the contrary, (i) all payments owing by CDS hereunder Securities and Exchange Commission. Confidential treatment has been requested with respect to development activities the omitted portions. Development Costs chargeable under this Agreement, SGEN will use its project accounting systems, as consistently applied across all its projects. Within [***] after the beginning of [***], SGEN shall provide to GNE a report detailing all Development Costs incurred during such 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 the number of FTEs dedicated to Development Payments, Compounded Development Payments, Determined Disputed Costs and Compounded Disputed Costs (as all defined in activities during that calendar quarter accompanied by 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 associated cost of such date; (ii) all payments owing FTEs at the SGEN FTE Rate. Such report shall be accompanied by Alimera hereunder with respect a [***]. Such report will provide information on out-of-pocket expenses incurred during the [***] at a sufficient level of detail to development activities prior enable GNE to evaluate the Amendment Effective Date are hereby deemed fully paid reasonableness of such expenses. Such report will be accompanied by Alimera (or waived, to an itemized invoice for 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 beforeduring the [***]. GNE shall pay SGEN for such Development Costs incurred within [***] of receipt of a true and correct invoice. As between the Parties, GNE shall be responsible for all costs and expenses incurred by or on and after the Amendment Effective Date)behalf of GNE, and instead Alimera its Affiliates, or its Sublicensees in connection with Development of Licensed Products. All Development Costs shall have sole liability thereforbe recorded in accordance with GAAP.
Appears in 1 contract
Development Costs. With respect The Parties shall each be responsible for their respective share, as defined in this Section 4.5, of all Joint Development Costs. Mundipharma shall be responsible for the "Mundipharma Share" of Joint Development Costs, which share shall initially be forty percent (40%) of the Joint Development Costs and shall become fifty percent (50%) of the Joint Development Costs (the "50/50 Threshold") (a) in the calendar quarter after Mundipharma receives Conditional Approval or (b) if such Conditional Approval is not obtained, the later of (i) the calendar quarter of the first Drug Approval in the EU of the Product in the Lead Indication or First Line PTCL, and (ii) the first calendar quarter in which the Development Cost Differential equals or exceeds fifteen million Dollars ($15,000,000); provided, if the Development Cost Differential does not equal or exceed fifteen million Dollars ($15,000,000) by December 31, 2019, then Allos shall be required to activities prior remit the difference between fifteen million Dollars ($15,000,000) and the Development Cost Differential as of such date to Mundipharma on or before January 31, 2020 and thereafter the Mundipharma Share shall be fifty percent (50%). For purposes of this Section 4.5, the "Development Cost Differential" means the difference between (A) the cumulative amount of Joint Development Costs borne by Mundipharma (whether as reimbursement to Allos pursuant to Section 7.2(a) or as Joint Development Costs directly incurred by Mundipharma to the Amendment Effective Date, each Party was to pay [*] of the total Direct extent that such Joint Development Costs of a Product incurred in accordance exceed Allos' reimbursement to Mundipharma pursuant to Section 7.2(b)), together with the Development Budget any Joint Manufacturing Costs (as defined in the Original Supply Agreement) borne by MMCO pursuant to the Supply Agreement, and (B) the cumulative amount of Joint Development Costs that Mundipharma would have borne if Mundipharma had been responsible for fifty percent (50%) of Joint Development Costs (rather than forty percent (40%) of Joint Development Costs). Notwithstanding anything , together with any Joint Manufacturing Costs (as defined in the Supply Agreement) that MMCO would have borne pursuant to the Supply Agreement if MMCO had been responsible for fifty percent (50%) (rather than forty percent (40%)) of Joint Manufacturing Costs under the Supply [ * ] = Certain confidential information contained in this Article 6 document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 24b-2 of this Agreement or in any the Securities Exchange Act of 1934, as amended. Agreement. Allos shall be responsible for the Allos Share of Joint Development Costs as well as for all costs and expenses of the Allos Studies. The Party conducting an Incremental Study shall be solely responsible for all costs and expenses of such Incremental Study, unless the other provision of this Agreement to the contrary, Party exercises its Opt-In Right 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 such study 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 accordance 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 requiredSection 4.4(c)(v), 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.
Appears in 1 contract
Samples: License, Development and Commercialization Agreement (Allos Therapeutics Inc)
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 [*]-INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED WITH THE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES AND EXCHANGE ACT OF 1934, AS AMENDED. 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.
Appears in 1 contract
Development Costs. With respect (a) Initial Studies, U.S. Studies, Pediatric Studies.
(i) Subject to activities prior Sections 4.9(a)(ii), 4.9(a)(iii) and 4.9(b)(i), AMAG shall be solely responsible for all costs and expenses it incurs to conduct the Amendment Initial Studies, U.S. Studies and Pediatric Studies. AMAG acknowledges that based on Regulatory Authority communications as of the Effective Date, each Party was the Initial Studies are highly beneficial to pay support Regulatory Approval and Commercialization in the Field in the Licensed Territory. AMAG shall keep complete and accurate records of all Out-of-Pocket Costs it incurs to conduct the Initial Studies. [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
(ii) If Takeda assumes responsibility for an Initial Study pursuant to Section 4.4(a)(ii), [***], Within thirty (30) days after the end of each calendar quarter during which Takeda is conducting an Initial Study, Takeda shall provide the total Direct JDC with a reasonably detailed statement setting forth all [***].
(iii) [***]
(b) Changes to Initial Studies, U.S. Studies, Pediatric Studies; Future Required Studies.
(i) [***] All Development Costs of activities conducted by a Product incurred Party for an Increase in Scope shall be in accordance with the Development Budget (as defined in Plan, and the Original Agreement). Notwithstanding anything other Party shall have the right to use the resulting data pursuant to the licenses granted 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 Within thirty (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 (iii30) subject to Sections 3.1.1 and 3.1.2, from and days after the Amendment Effective Dateend of each calendar quarter during which AMAG, CDS will have no liability whatsoever hereunder for any pastTakeda and/or Takeda’s sublicensee is conducting Development activities resulting from an Increase in Scope, present or future development costsAMAG and/or Takeda, including Direct Development Costs (which includes those incurred beforeas applicable, on and after shall provide the Amendment Effective Date), and instead Alimera shall have sole liability thereforJDC with a reasonably detailed statement setting forth [***].
Appears in 1 contract
Samples: License, Development and Commercialization Agreement (Amag Pharmaceuticals Inc.)
Development Costs. With respect to Except as provided in Section 4.3, PRAECIS shall pay seventy-five percent (75%), and Synthelabo shall pay twenty-five percent (25%), of all Development Costs incurred in carrying out the Core Development Plan. The foregoing cost sharing provisions shall also apply if PRAECIS enters into an agreement with a Third Party under which such Third Party shall undertake PRAECIS' development activities prior pursuant to the Amendment Effective DateCore Development Plan, each Party was unless PRAECIS and Synthelabo shall agree otherwise. Synthelabo shall pay all Development Costs which are incurred in carrying out the Supplemental Development Plan, provided that PRAECIS shall reimburse Synthelabo for seventy-five percent (75%) of such Development Costs to pay [*] the extent the results of the total Direct Development Phase activities in respect of which such Development Costs were incurred are used to seek or obtain Registration Approvals or Reimbursement Approvals in the United States. If (i) PRAECIS or its licensee or sublicensee wishes to use both outside of a Product the Territory and outside of the United States the results of the Supplemental Development Studies obtained by Synthelabo in carrying out the Supplemental Development Plan and (ii) PRAECIS is not required hereunder to reimburse Synthelabo 75% of the Development Costs incurred in accordance connection with the such Supplemental Development Budget (as defined Studies, then PRAECIS and Synthelabo shall meet to negotiate in the Original Agreement). Notwithstanding anything in this Article 6 good faith an equitable sharing 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 such Development Costs. Notwithstanding anything in this Article 6 of this Agreement or in any other provision of this Agreement Anything herein to the contrarycontrary notwithstanding, (i) all payments owing each of Synthelabo and PRAECIS shall have full and complete access to and use of the safety data of the other regarding each Licensed Product, and each may use the safety data of the other for Advertising and Promotion, in each case without any cost or reimbursement therefor and (ii) regulatory submission, registration fees and maintenance fees in the Territory shall be paid by CDS hereunder with respect Synthelabo, and registration fees and maintenance fees outside the Territory shall be paid by PRAECIS. If a party is claiming reimbursement pursuant to development activities prior this Section 4.5, then within forty-five (45) days after the end of a calendar quarter during which the Development Costs for which reimbursement is being claimed were incurred, a party will submit to the Amendment Effective Date are hereby deemed fully other a statement (each a "Development Cost Statement") itemizing in reasonable detail such Development Costs and setting forth the total amount, if any, of such Development Costs to be reimbursed by the other party pursuant to this Section 4.5. Such reimbursement amounts shall be paid by CDS within twenty (or waived20) days after receipt of a Development Cost Statement, except to the extent such waiver may be required)Development Cost Statement is being disputed in good faith. Except as otherwise provided herein, including any each party shall assume full responsibility for its own 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 thereforCosts.
Appears in 1 contract
Development Costs. With respect to activities prior a) Intuitive shall be solely responsible for all costs and expenses incurred in conducting the development work related to the Amendment Effective Date8mm Stapler (including for any such work performed by Cardica, each Party was at Intuitive’s request).
b) With regard to pay costs and expenses incurred in conducting the development work related to the 8mm Reload (“Reload Development Costs”), Intuitive shall contribute [*] of the total Direct Reload Development Costs during the first two and one half years after the Effective Date (the “Joint Development Period”), up to a maximum amount not to exceed [*] per year and [*] in total (collectively, the “Cap”). Within thirty (30) days after the end of each quarter in the Joint Development Period, each party shall provide the other with documentation setting forth Reload Development Costs incurred by them during the preceding quarter. Intuitive will then calculate each Party’s respective share of the Reload Development Costs and, in the event Cardica incurred more costs than its [*] share, Intuitive shall pay to Cardica the balance due, subject to the Cap, for that quarter within thirty (30) days after the receipt of documentation from Cardica setting forth its Reload Development Costs. In the event that Intuitive incurred more Reload Development Costs than its [*] share in a given quarter, then any amount incurred by Intuitive over and above its share shall be applied as credit to subsequent quarters. For avoidance of doubt, Intuitive shall not be credited for any Reload Development Costs for Reload Development Work that Cardica has not authorized. In the event of a Product dispute between the parties with regard to Development Costs incurred in accordance with by either party, the Development Budget (parties shall proceed 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, set forth above with respect to activities on and after the Amendment Effective Date, subject to Sections 3.1.2, Alimera will be solely responsible forundisputed amount, and any disputed amounts shall pay one hundred percent be resolved pursuant to the Article 10 of the License Agreement (100%) of, all development costs of a Product, including Direct Development CostsDispute Resolution). Notwithstanding anything [*] = Certain confidential information contained in this Article 6 document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
c) Development Costs shall include parties’ internal (calculated at the FTE rate set forth below) and out of pocket costs and expenses incurred to conduct the development work under the Development Plan. For the purpose of this Agreement or in any other provision of this Agreement to the contraryDevelopment Agreement, (i) all payments owing by CDS hereunder with respect to “FTE Rate” means the cost of an FTE performing 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 work under the Original Agreement Development Plan, which rate shall be calculated as (a) for an employee, [*] of such datethat employee’s annual salary, up to a maximum of [*] per FTE per year, or (b) for a contractor, that contractor’s hourly rate of pay, up to a maximum of [*] per hour; and (ii) all payments owing by Alimera hereunder with respect “FTE” means the equivalent of a full-time individual’s work, at [*] hours per year, for a twelve (12)-month period, performing development work under the Development Plan. For clarity, the Parties intend the FTE to development activities prior be a unit of measurement used to calculate the amount of time dedicated to the Amendment Effective Date are hereby deemed fully paid performance of this Development Agreement. One FTE may constitute work performed by Alimera (an individual whose time is dedicated solely to this Development Agreement or waived, to the extent such waiver may be required)comprised of the efforts of several individuals, including any each of whom dedicates only part of his or her time to work under this 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.
Appears in 1 contract
Samples: License Agreement (Cardica Inc)