Shared Development Costs Sample Clauses

Shared Development Costs. Rib-X will pay [***] percent ([***]%) and Sanofi will pay [***] percent ([***]%) of all Shared Development Costs to the extent incurred after the US Profit Share Option Exercise Date. Commencing upon the US Profit Share Option Exercise Date, each Party will report its actual Shared Development Costs to the other Party within thirty (30) Business Days after the end of each Calendar Quarter in each case tracked by activity to the amounts for such activities shown on the then current Development Plan. Notwithstanding the foregoing, within fifteen (15) Business Days after the end of the third month of each Calendar Quarter, Rib-X and Sanofi will each provide to the other an estimate of Shared Development Costs for such Calendar Quarter. The Parties will seek to resolve any questions related to any such reports within ten (10) Business Days after receipt. If a balancing payment is due to ensure that the Shared Development Costs have been allocated in accordance with the first sentence of this Section, the Party due the payment will invoice the other Party at the end of each Calendar Quarter for such other Party’s share of Shared Development Costs for such Calendar Quarter calculated in accordance with this Section, and such paying Party will pay amounts due with respect to Shared Development Costs under this Section within forty-five (45) days after receipt of the corresponding invoice.

Shared Development Costs. Except as otherwise provided herein, each Party shall bear fifty percent (50%) of all Shared Development Costs.

Shared Development Costs. The Xencor Sharing Percentage specified in the Cost Sharing Election Notice shall apply from the Option Exercise Date until the end of the first full calendar year after the Option Exercise Date. Xencor agrees and acknowledges that Xencor’s failure to provide any such notice within such period shall be deemed to constitute Xencor’s election to share […***…]% of Shared Development Costs.

Shared Development Costs. Within sixty (60) days after exercising its Option Right with respect to each of Program 2 and Program 4, Roche shall provide BPM with an initial Development Plan and a budget for such Program outlining the planned activities and related Development Costs (“Shared Development Cost Budget”) for such Development Plan. The Shared Development Cost Budget shall include the anticipated Development Costs pursuant to the Development Plan for the remainder of the then current Calendar Year and each of the next two (2) Calendar Years expected to be incurred by each Party and in total. Thereafter, annually, the Development Plan and the Shared Development Cost Budget shall be updated by the JDC such that the Shared Development Cost Budget shall always reflect the planned activities under the Development Plan for three (3) Calendar Years. If a Party’s actually incurred Development Costs for the current Calendar Year exceeds […***…] of its portion of the Shared Development Cost Budget, such excess portion of Development Costs shall be entirely borne by the Party that exceeded its portion of the Shared Development Cost Budget provided that (A) BPM approved the amount included in the Shared Development Cost Budget specifically attributable to the activities conducted by BPM under such Shared Development Cost Budget, and (B) the JDC shall have the right during a Calendar Year to update the Shared Development Cost Budget in the event of (i) faster than planned Clinical Study enrollment, (ii) written guidance or requirements from a Regulatory Authority that would result in amendments to the Development Plan or (iii) mutual agreement by the Parties to amend the Development Plan, each of (i), (ii) and (iii) an “Allowable Exception”. Additional Development Costs incurred in a Calendar Year resulting from an Allowable Exception shall be subject to sharing of Development Costs pursuant to Section 12.6.

Shared Development Costs. With respect to Joint Development Activities conducted pursuant to Section 4.2(b) or Section 4.3 directed to obtaining Regulatory Approval for any Indication, excluding the Ovid Ongoing Trials, Ovid shall bear [***] and Licensee shall bear [***] of all Development Costs for such Joint Development Activities. No later than [***] after the beginning of each Calendar Quarter during which a Party will perform any Joint Development Activities pursuant to Section 4.2(b) or Section 4.3 in such Calendar Quarter, such Party shall submit to the other Party a statement setting forth the Development Costs incurred, including the other Party’s share (calculated in accordance with the foregoing sentence) of (i) estimated Development Costs for the then current quarter; (ii) variances from prior invoiced estimates and actual Development Costs; and (iii) Development Costs incurred by or on account of such Party in the past quarter not previously invoiced. Such invoice shall include a reasonably detailed report for such Development Costs, including reasonable supporting documents. The other Party shall pay the amount invoiced within [***] after the receipt of the invoice, subject to the other Party’s right to audit the invoicing Party’s records and books related to such costs as provided in Section 9.4. If both Parties will perform Joint Development Activities pursuant to Section 4.2(b) or Section 4.3 under the Development Plan in such Calendar Quarter, the Parties shall consolidate the payments for such Calendar Quarter into a single payment from one Party to the other Party, as applicable.

Shared Development Costs. Except as set forth in Section 5.3 (▇▇▇▇▇▇▇’s Opt-Out Right), and further subject to this Section 5.2.4 (Shared Development Costs), (x) during the Development Term, subject to Section 11.4.2 (Overruns), the Parties will share Development Costs incurred in the performance of Shared Global Development Activities undertaken in accordance with the Joint Development Plan and Joint Development Budget and (y) the Parties will share Development Costs incurred in the performance of Shared Global Development Activities undertaken in accordance with Section 3.2.3 (Expedited Dispute Resolution) or Section 5.2.3(b), as applicable, with GSK bearing [**] percent ([**]%) of such Development Costs and Mersana bearing [**] percent ([**]%) of such Development Costs. (a) Notwithstanding the foregoing, to the extent that ▇▇▇▇▇▇▇’s aggregate share of Development Costs (including all Deemed Buy-In payments) exceeds [**] Dollars ($[**]) (the “Mersana Development Cost Cap”), then unless and until Mersana exercises its Profit Share Election pursuant to Section 9.1.1 (Exercise of Profit Share Election), ▇▇▇▇▇▇▇’s portion of any additional Development Costs (including any -52- Deemed Buy-In payments) incurred above the Mersana Development Cost Cap (such Development Costs, “Cap Excess Amounts”) shall be borne by GSK; provided that (i) any such Cap Excess Amounts for which GSK is responsible pursuant to this Section 5.2.4(a) shall accrue with interest in accordance with Section 11.4.4 (Cap Excess Amounts), (ii) such Cap Excess Amounts (and any accrued interest thereon) shall be, [**] repaid in full or in part by Mersana or offset against any future Regulatory Milestone Payments, Sales Milestone Payments or Royalties in accordance with Section 11.4.4 (Cap Excess Amounts), and (iii) if Mersana exercises its Profit Share Election pursuant to Section 9.1.1 (Exercise of Profit Share Election), the Mersana Development Cost Cap would automatically expire upon the Profit Share Start Date and ▇▇▇▇▇▇▇ would thereafter recommence bearing its [**] percent ([**]%) share of Development Costs in accordance with this Section 5.2.4 (Shared Development Costs), subject to Section 5.2.4(b). (b) Notwithstanding anything to the contrary set forth herein, from and after the first expiry of the Royalty Term of a Licensed Product in [**] (the “Development Cost Share End Date”), (A) ▇▇▇▇▇▇▇’s obligation to share in [**] percent ([**]%) of such Development Costs shall terminate; provided, however, that Mersana s...

Shared Development Costs. With respect to (i) all Post-Approval Cross-Territory Mandatory Studies for the treatment of HAE that are included in the Cross-Territory Clinical Development Plan as of the Effective Date] and (ii) [any other Post-Approval Cross-Territory Mandatory Studies for the treatment of HAE or any Future Cross-Territory Studies, in each case, that are added to the Cross-Territory Clinical Development Plan in accordance with Section 4.2.1 (Cross-Territory Clinical Development Plan), the Parties will share, [***], in each case, in accordance with the Cross-Territory Clinical Development Plan and Shared Development Budget (such costs, “Shared Cross-Territory Development Costs”) in accordance with the terms of Section 4.4.3 (Shared Cross-Territory Development Costs).

Shared Development Costs. 43 3.3 Right to Conduct Permitted Combination Studies 44 3.3.1 Permitted Combination Studies 44 3.3.2 Notice 44 3.4 Right to Support Investigator Sponsored Studies 45 3.4.1 Use of Clinical Data 45 3.5 Development Plans. 45 3.5.1 Initial Global Development Plan 45 3.5.2 Additional Global Development Plan 45 3.6 Development Diligence 45 3.6.1 Novartis Development Diligence 46 3.6.2 BeiGene Development Diligence 46 3.6.3 Standards of Conduct 46 3.7 Development Records 46 3.8 Development Updates During Option Period 47 3.9 Development Updates After License Effective Date 47 Article 4 REGULATORY 47 4.1 Regulatory Matters. 47 4.1.1 Responsibility 47 4.1.2 Review of Regulatory Materials/Approval of Regulatory Filings 48 4.1.3 Communication with Regulatory Authorities 49 4.1.4 Notice of Regulatory Meetings 50 4.1.5 Support by ▇▇▇▇▇▇▇ and Novartis 51 4.1.6 Rights of BeiGene and Novartis 51 4.1.7 Additional Actions by BeiGene 52 4.2 Regulatory Materials. 52 4.2.1 Existing Regulatory Materials 52 4.2.2 Regulatory Transition Activities 53 4.2.3 New Regulatory Materials 53 4.2.4 Regulatory Materials in BeiGene Territory 53 4.3 Right of Reference; Access to Data. 54 Article 5 COMMERCIALIZATION 55 5.1 General. 55 5.1.1 Novartis Responsibilities 55 5.1.2 Permitted Commercialization Activities 55 5.2 Commercialization Plan. 56 5.2.1 Branding Strategy 56 5.2.2 Commercialization Plan 57 5.3 […***…] 57 5.3.1 Novartis […***…] 57 5.3.2 BeiGene […***…] 57 5.4 Diligence 58 5.5 Medical Affairs Activities 58 5.5.1 Performance by Local Affiliates 58 5.5.2 Medical Affairs Plan 58 5.5.3 Medical Affairs Reports 58 5.5.4 Allocation of Certain Medical Liaisons Activities 58 5.6 BeiGene Co-Detailing Rights. 58 5.7 Compliance 60 Article 6 PHARMACOVIGILANCE; SAFETY; DATA PRIVACY 60 6.1 Pharmacovigilance 60 6.2 Global Safety Database 61 6.3 Data Processing Agreement 61 Article 7 ASSISTANCE; DISCLOSURE OF KNOW-HOW; TECHNOLOGY TRANSFER; MANUFACTURING 62

Shared Development Costs. (i) Subject to Section 4.4.1(c)(ii) (Shared Development Costs), with respect to (A) all Post-Approval Cross-Territory Mandatory Studies for the treatment of HAE that are included in the Cross-Territory Clinical Development Plan as of the Original Effective Date and (B) any other Post-Approval Cross-Territory Mandatory Studies for the treatment of HAE or any Future Cross-Territory Studies, in each case ((A) and (B)), that are added to the Cross-Territory Clinical Development Plan in accordance with Section 4.2.1 (Cross-Territory Clinical Development Plan), the Parties will share, [***], in each case, in accordance with the Cross-Territory Clinical Development Plan and Shared Development Budget (such costs, “Shared Cross-Territory Development Costs”) in accordance with the terms of Section 4.4.3 (Shared Cross-Territory Development Costs). (ii) If (A) the Parties agree to update the Cross-Territory Clinical Development Plan (including the Shared Development Budget) to include Clinical Trial sites in Japan for any Cross-Territory Clinical Study and (B) the PMDA agrees in advance that such Cross-Territory Clinical Study (including the Clinical Trial sites in Japan) will be sufficient to obtain Regulatory Approval in Japan for use of the Licensed Product without the need for additional Japan-only Clinical Trials, then [***]; provided that, if a Cross-Territory Clinical Study has been initiated as of or after the Original Effective Date and is subsequently amended to include Clinical Trial sites in Japan, then at the time the Parties agree to include Clinical Trial sites in Japan in such Cross-Territory Clinical Study, Ionis will provide to Otsuka a written report of the [***] (the “Ionis Incurred Development Costs”). Such written report shall include [***]. Ionis will provide an invoice to Otsuka for [***] of the Ionis Incurred Development Costs, and Otsuka will pay such amount [***] after receipt of such invoice [***]; provided that, if Otsuka disputes any invoiced amount, then Otsuka will pay the undisputed invoiced amount [***] and will pay any disputed amounts [***] following resolution of the dispute and determination that such amounts are owed; and provided, further that Otsuka shall have the right to [***].