CONFIDENTIAL PORTIONS OMITTED AND FILED SEPARATELY WITH THE COMMISSION. LICENSE AGREEMENT PAGE 7
CONFIDENTIAL PORTIONS OMITTED AND FILED SEPARATELY WITH THE COMMISSION. Spectrum shall retain control over management of the chemical, pharmaceutical and other process development related to the manufacturing of the Product (including API and Bulk Product), including stability testing; provided, that Spectrum shall keep Topotarget informed of proposed process development or other changes related to the manufacturing of the Product (including API and Bulk Product) and shall obtain Topotarget’s prior written approval for any Material Change, not to be unreasonably withheld or delayed. In addition, Spectrum shall have the sole right and obligation to prepare and submit the drug master file (as such term is defined in the 21 C.F.R., Section 314.420) to the FDA for the manufacture of the API, and Topotarget shall reasonably cooperate with Spectrum in connection therewith, including by providing to Spectrum any information and records in Topotarget’s possession that is required for the preparation and filing of such drug master file. Spectrum shall share a copy of the drug master file with Topotarget before submission to the FDA (and any subsequent versions of the drug master file) and shall in good faith consider to incorporate any feedback provided by Topotarget. Spectrum shall not make any material changes in the drug master file without the prior approval of Topotarget, which shall not be unreasonably withheld or delayed. For avoidance of doubt, the foregoing drug master file is included in the right of reference granted by Spectrum to Topotarget pursuant to Section 4.6. Spectrum agrees to supply API, Bulk Product and NPP Product to Topotarget (or its designees) for use, distribution and sale in the Topotarget Territory, which supply shall be governed by the terms of this Section 5.6. The price for such supplies of API, Bulk Product and NPP Product (or components thereof) will not exceed the Cost of Goods (with “Spectrum” substituted for “Topotarget” in Sections 1.28 and 1.110) plus [***] percent ([***]%). In light of the foregoing, and upon Topotarget’s request, Spectrum agrees to reasonably cooperate with Topotarget in obtaining, and Spectrum will use Commercially Reasonable Efforts to obtain, from the FDA or other Regulatory Authority a Certificate of Pharmaceutical Product (CPP) with respect to Product manufactured by any Third Party manufacturers engaged by Spectrum to produce commercial supplies of API and/or Product. If necessary, Spectrum will serve as the point of contact with the FDA or other Regulatory Authority with ...
CONFIDENTIAL PORTIONS OMITTED AND FILED SEPARATELY WITH THE COMMISSION. IDEC/Schering AG Supply Agreement 9 June 1999 11
CONFIDENTIAL PORTIONS OMITTED AND FILED SEPARATELY WITH THE COMMISSION. Within [***] ([***]) days of Spectrum’s request and thereafter periodically throughout the Term, Topotarget shall transfer to Spectrum, its Affiliate or any Third Party manufacturers selected by Spectrum, all Information, including the specifications for the API and/or Product, Controlled by Topotarget at such time that is necessary or useful to enable Spectrum, its Affiliate or a Third Party manufacturer (as appropriate) to replicate the process employed by or on behalf of Topotarget to manufacture and test API and/or Product. Topotarget shall take commercially reasonable steps to ensure the smooth and timely transfer of the manufacturing process for API and/or Products to Spectrum, its Affiliate or Third Party manufacturer. Spectrum acknowledges and agrees that Topotarget may condition its agreement to transfer (or to permit Spectrum to transfer) any Topotarget manufacturing technology or Information to a Third Party manufacturer on the execution of a confidentiality agreement between such Third Party manufacturer and Spectrum that contains obligations of confidentiality and non-use no less stringent than those of Article 11 of this Agreement. The expenses of each Party incurred in such transfer shall be borne by [***]. Any costs and expenses payable to the then-current and new Third Party manufacturers (“Third Party Manufacturer Costs”) shall be borne [***]; provided, however, that if such Third Party manufacturer is utilized by [***] (directly (other than as a result of the circumstances described in clauses (i) and (ii) of the second paragraph of Section 5.6(b) or through [***]) for commercial supplies of the API and/or Product, [***] shall reimburse [***] on a pro rata basis calculated based on good faith, estimated demand for the Products in the Party’s respective territories during the [***] ([***]) year period after the establishment of such Third Party manufacturer, provided that (x) the foregoing shall not apply to any Third Party Manufacturer Costs in respect of a Third Party manufacturer established as a second source, which costs are governed by the last sentence of this subsection (e), and (y) if any of the Third Party Manufacturer Costs are incurred solely due to requirements for the Topotarget Territory, Topotarget shall reimburse Spectrum for [***] percent ([***]%) of such Third Party Manufacturer Costs. The foregoing reimbursement obligation shall survive termination of this Agreement absent express agreement to the contrary by the Parti...
CONFIDENTIAL PORTIONS OMITTED AND FILED SEPARATELY WITH THE COMMISSION. STRATEC Development Agreement Signature version
CONFIDENTIAL PORTIONS OMITTED AND FILED SEPARATELY WITH THE COMMISSION. STRATEC Development Agreement Signature version and specifications, test data, charts and graphs, manufacturing procedures, operation sheets, bills of material and lists and any other information, formulas, methods or equipment relating to Pre-Existing QUOTIENT Technology, Pre-Existing STRATEC Technology and any New Technology as described hereunder.
CONFIDENTIAL PORTIONS OMITTED AND FILED SEPARATELY WITH THE COMMISSION. STRATEC Development Agreement Signature version 1 Execution of Agreement 7 Jan 2014 [***] 2 Completion of phase 1 and mutual sign-off of PDR, Reliability Program Plan, Acceptance Criteria and Shipping Criteria/ breadboard testing 31May 2014 [***] 3 Approval of Hardware Design Specification Documents 31 July 2014 [***] 4 Completion of phase 2 and delivery of first Prototypes for assay integration 31 Oct 2014 [***] 5 Acceptance of Prototypes 15 Dec 2014 [***] 6 Completion of phase 3 and delivery of first Validation instruments 31 Oct 2015 [***] 7 Acceptance of Validation instruments 31 Jan 2016 [***] 8 Completion of phase 4 and delivery of first series units for testing and documentation 31 July 2016 [***] Total Amount Due Euro
CONFIDENTIAL PORTIONS OMITTED AND FILED SEPARATELY WITH THE COMMISSION. STRATEC Development Agreement Signature version e. Milestone 4: Upon STRATEC’s completion of the prototype phase (Milestone 4) STRATEC shall provide QUOTIENT with a written notice thereof including evidence that Shipping Criteria have been met. Within ten (10) working days after QUOTIENT’S receipt of such notice QUOTIENT is requested to (i) release the shipment of the Instrument Prototype unit(s) or (ii) to decline STRATEC’s achievement of Shipping Criteria, providing STRATEC with a detailed written justification thereof. If QUOTIENT declines STRATEC’s achievement of Shipping Criteria the procedure as outlined in section (j) of this paragraph shall apply. If QUOTIENT releases the shipment of the Instrument Prototype unit(s) or fails to decline STRATEC’s achievement of Shipping Criteria within 10 working days after QUOTIENT’S receipt of STRATEC’s notice STRATEC shall be allowed to both ship the Instrument Prototype unit(s) and invoice QUOTIENT for the amount due. QUOTIENT shall remit Payment to STRATEC within thirty (30) days of receipt of the invoice.
CONFIDENTIAL PORTIONS OMITTED AND FILED SEPARATELY WITH THE COMMISSION. STRATEC Development Agreement Signature version i. Milestone 8: Within a period not exceeding thirty (30) days following STRATEC’s declaration of production readiness QUOTIENT shall complete all of QUOTIENT’S procedures required and authorize STRATEC to release the Instrument into series production. If QUOTIENT declines to authorize STRATEC to release the Instrument into series production QUOTIENT is requested to provide STRATEC with a detailed written justification thereof and the procedure as outlined in Section k of this paragraph shall apply.
CONFIDENTIAL PORTIONS OMITTED AND FILED SEPARATELY WITH THE COMMISSION. STRATEC Development Agreement Signature version (such approval not to be unreasonably withheld) for review and analysis of the conformity of the Instrument (whether in Breadboard, Prototype, Validation or Production form) to the relevant criteria. The Parties shall provide such independent expert or laboratory with all records and documentation relevant to the determination of the matter. The costs associated with such analysis shall be paid by the Party whose assessment of the conformity of the Instrument with the relevant criteria was mistaken.
