Commercial Milestones (a) Within [*****] calendar days after the end of the first Calendar Year in which aggregate annual Net Sales for that Calendar Year for the Licensed Product in the Territory reach any threshold indicated in the Commercial Milestone Events listed below, EverInsight shall notify VistaGen of the achievement of such Commercial Milestone Event and VistaGen shall invoice EverInsight for the corresponding non-refundable, non-creditable Milestone Payment set forth below and EverInsight shall remit payment to VistaGen within [*****] Business Days after the receipt of the invoice, as described in Section 8.6 (Currency; Exchange Rate; Payments). Annual Net Sales Milestones for Licensed Product Milestone Payments (in Dollars) (each a “Commercial Milestone Event”):
(1). [*****]
(2). [*****]
(3). [*****]
(4). [*****]
(5). [*****]
(b) For the purposes of determining whether a Net Sales Milestone Event has been achieved, Net Sales of Licensed Product(s) in the Territory shall be aggregated. For clarity, the annual Net Sales Milestone Payments set forth in this Section 8.3 (Commercial Milestones) shall be payable only once, upon the first achievement of the applicable Commercial Milestone Event, regardless of how many times such Commercial Milestone Event is achieved.
(c) If a Commercial Milestone Event in Section 8.3 (Commercial Milestones) is achieved and payment with respect to any previous Commercial Milestone Event in Section 8.3 has not been made, then such previous Commercial Milestone Event shall be deemed achieved and EverInsight shall notify VistaGen within fifteen (15) calendar days of such achievement. VistaGen shall then invoice EverInsight for such unpaid previous Commercial Milestone Event(s) and EverInsight shall pay VistaGen such unpaid previous milestone payment(s) within thirty (30) Business Days of receipt of such invoice.
(d) In the event that, VistaGen believes any Commercial Milestone Event under Section 8.3(a) has occurred but EverInsight has not given VistaGen the notice of the achievement of such Commercial Milestone Event, it shall so notify EverInsight in writing and shall provide to EverInsight data, documentation or other information that supports its belief. Any dispute under this Section 8.3(d) (Commercial Milestones - subsection (d)) that relates to whether or not a Commercial Milestone Event has occurred shall be referred to the JSC to be resolved in accordance with ARTICLE 3 (Governance) and shall be subject to resolution in accordance with Section 14.10 (Dispute Resolution). The Milestone Payments made for each Commercial Milestone Event shall be non-creditable and non-refundable.
Technology Research Analyst Job# 1810 General Characteristics
Human Leukocyte Antigen Testing This plan covers human leukocyte antigen testing for A, B, and DR antigens once per member per lifetime to establish a member’s bone marrow transplantation donor suitability in accordance with R.I. General Law §27-20-36. The testing must be performed in a facility that is: • accredited by the American Association of Blood Banks or its successors; and • licensed under the Clinical Laboratory Improvement Act as it may be amended from time to time. At the time of testing, the person being tested must complete and sign an informed consent form that also authorizes the results of the test to be used for participation in the National Marrow Donor program.
RE-WEIGHING PRODUCT Deliveries are subject to re- weighing at the point of destination by the Authorized User. If shrinkage occurs which exceeds that normally allowable in the trade, the Authorized User shall have the option to require delivery of the difference in quantity or to reduce the payment accordingly. Such option shall be exercised in writing by the Authorized User.
Manufacturing Technology Transfer Upon AbbVie’s written request with respect to a given Collaboration CAR-T Product and Licensed Product, Caribou shall effect a full transfer to AbbVie or its designee (which designee may be an Affiliate or a Third Party Provider) of all Materials and Know-How Controlled by Caribou relating to the then-current process for the Manufacture of such Collaboration CAR-T Product and any corresponding Licensed Products (each, a “Manufacturing Process”). Caribou shall provide, shall cause its Affiliates to provide, and shall use Commercially Reasonable Efforts to assist AbbVie in causing all Third Party Providers to provide, all reasonable assistance requested by AbbVie to enable AbbVie (or its Affiliate or designated Third Party Provider, as applicable) to implement each Manufacturing Process at the facilities designated by AbbVie. If requested by AbbVie, such assistance shall include facilitating the entering into of agreements with applicable Third Party suppliers relating to such Collaboration CAR-T Product and any corresponding Licensed Products. Without limitation of the foregoing, in connection with the Manufacturing Process and related transfer:
(a) Caribou shall, and shall cause its Affiliates to, make available to AbbVie (or its Affiliate or designated Third Party Provider, as applicable), and shall use Commercially Reasonable Efforts to assist AbbVie in causing all Third Party Providers to make available to AbbVie, from time to time as AbbVie may request, all Materials and Manufacturing-related Know-How Controlled by Caribou relating to each Manufacturing Process, including methods, reagents and processes and testing/characterization Know-How, and all documentation constituting material support, performance advice, shop practice, standard operating procedures, specifications as to Materials to be used, and control methods, that are necessary or reasonably useful to enable AbbVie (or its Affiliate or designated Third Party manufacturer, as applicable) to use and practice such Manufacturing Process;
(b) Caribou shall cause all appropriate employees and representatives of Caribou and its Affiliates, and shall use Commercially Reasonable Efforts to assist AbbVie in causing all appropriate employees and representatives of Third Party Providers, to meet with employees or representatives of AbbVie (or its Affiliate or designated Third Party Provider, as applicable) at the applicable manufacturing facility at mutually convenient times to assist with the working up and use of each Manufacturing Process and with the training of the personnel of AbbVie (or its Affiliate or designated Third Party Provider, as applicable) to the extent necessary or reasonably useful to enable AbbVie (or its Affiliate or designated Third Party Provider, as applicable) to use and practice such Manufacturing Process;
(c) Without limiting the generality of this Section 4.4.2, Caribou shall cause all appropriate analytical and quality control laboratory employees and representatives of Caribou and its Affiliates, and shall use Commercially Reasonable Efforts to assist AbbVie in causing all appropriate analytical and quality control laboratory employees and representatives of Third Party Providers, to meet with employees or representatives of AbbVie (or its Affiliate or designated Third Party Provider, as applicable) at the applicable manufacturing facility and make available all necessary equipment, at mutually convenient times, to support and execute the provision of all applicable analytical methods and the validation thereof (including all applicable Know-How, Information and Materials Controlled by Caribou, and sufficient supplies of all primary and other reference standards);
(d) Caribou shall, and shall cause its Affiliates to, take such steps, and shall use Commercially Reasonable Efforts to assist AbbVie in causing Third Party Providers take such steps, as are necessary or reasonably useful to assist AbbVie (or its Affiliate or designated Third Party Provider, as applicable) in obtaining any necessary licenses, permits or approvals from Regulatory Authorities with respect to the Manufacture of the applicable Collaboration CAR-T Products and corresponding Licensed Products at the applicable facilities; and
(e) Caribou shall, and shall cause its Affiliates to, provide, and shall use Commercially Reasonable Efforts to assist AbbVie in causing Third Party Providers to provide, such other assistance as AbbVie (or its Affiliate or designated Third Party Provider, as applicable) may reasonably request to enable AbbVie (or its Affiliate or designated Third Party Provider, as applicable) to use and practice each Manufacturing Process and otherwise to Manufacture the applicable Collaboration CAR-T Products and corresponding Licensed Products.
DEVELOPMENT OR ASSISTANCE IN DEVELOPMENT OF SPECIFICATIONS REQUIREMENTS/ STATEMENTS OF WORK
Commercialization Reports Throughout the term of this Agreement and during the Sell-Off Period, and within thirty (30) days of December 31st of each year, Company will deliver to University written reports of Company’s and Sublicensees’ efforts and plans to develop and commercialize the innovations covered by the Licensed Rights and to make and sell Licensed Products. Company will have no obligation to prepare commercialization reports in years where (a) Company delivers to University a written Sales Report with active sales, and (b) Company has fulfilled all Performance Milestones. In relation to each of the Performance Milestones each commercialization report will include sufficient information to demonstrate achievement of those Performance Milestones and will set out timeframes and plans for achieving those Performance Milestones which have not yet been met.
TECHNICAL EVALUATION (a) Detailed technical evaluation shall be carried out by Purchase Committee pursuant to conditions in the tender document to determine the substantial responsiveness of each tender. For this clause, the substantially responsive bid is one that conforms to all the eligibility and terms and condition of the tender without any material deviation. The Institute’s determination of bid’s responsiveness is to be based on the contents of the bid itself without recourse to extrinsic evidence. The Institute shall evaluate the technical bids also to determine whether they are complete, whether required sureties have been furnished, whether the documents have been properly signed and whether the bids are in order.
(b) The technical evaluation committee may call the responsive bidders for discussion or presentation to facilitate and assess their understanding of the scope of work and its execution. However, the committee shall have sole discretion to call for discussion / presentation.
(c) Financial bids of only those bidders who qualify the technical criteria will be opened provided all other requirements are fulfilled.
(d) AIIMS Jodhpur shall have right to accept or reject any or all tenders without assigning any reasons thereof.
Sales Milestones (a) As to each Therapeutic Product, SANOFI-AVENTIS shall pay MERRIMACK up to a total of Sixty Million Dollars (US$60,000,000) upon the first achievement of the following Net Sales milestones, on a Therapeutic Product-by-Therapeutic Product basis:
(i) Total Worldwide Net Sales for such Therapeutic Product exceed $[**] in any four (4) consecutive calendar quarters $ [**]
(ii) Total Worldwide Net Sales for such Therapeutic Product exceed $[**] in any four (4) consecutive calendar quarters $ [**]
(iii) Total Worldwide Net Sales for Therapeutic Product exceed $[**] in any four (4) consecutive calendar quarters $ [**]
(b) Each milestone payment set forth in Section 8.4(a) shall be payable by SANOFI-AVENTIS upon the achievement of the related milestone event by SANOFI-AVENTIS and its Affiliates or sublicensees, and SANOFI-AVENTIS shall provide notice to MERRIMACK promptly upon achievement of such milestone event. SANOFI-AVENTIS shall pay MERRIMACK each such milestone payment within [**] days of such achievement of the related milestone event.
(c) For purposes of clarity, more than one of the Net Sales milestones set forth above may be earned in the same four (4) consecutive calendar quarter period with respect to a Therapeutic Product. For example, if total worldwide Net Sales with respect to a given Therapeutic Product have not achieved any of the lower sales milestone thresholds set forth in clause (i) or (ii) of Section 8.3(a) above in any previous four (4) consecutive calendar quarter period, but total worldwide Net Sales with respect to such Therapeutic Product exceed $[**] in a subsequent four (4) consecutive calendar quarter period, then all three milestone payments, totaling $60 Million, payable upon achievement of the sales milestone thresholds set forth in clause (i), (ii) and (iii) of Section 8.3(a) above shall become payable to MERRIMACK hereunder.
Development Milestones In addition to its obligations under Paragraph 7.1, LICENSEE specifically commits to achieving (either itself or through the acts of a SUBLICENSEE) the following development milestones in its diligence activities under this AGREEMENT: (a) (b).
