Development Milestones In addition to its obligations under Paragraph 7.1, LICENSEE specifically commits to achieving the following development milestones in its diligence activities under this AGREEMENT: (a) (b).
OUT OF STOCK, PRODUCT RECALLS, AND DISCONTINUED PRODUCTS H-GAC does NOT purchase the products sold pursuant to a Solicitation or Agreement. Contractor is responsible for ensuring that notices and mailings, such as Out of Stock or Discontinued Notices, Safety Alerts, Safety Recall Notices, and customer surveys, are sent directly to the Customer with a copy sent to H-GAC. Customer will have the option of accepting any equivalent product or canceling the item from Customer’s Purchase Order. Contractor is not authorized to make substitutions without prior approval.
Product Recall (a) If a recall is required by applicable Law, or if Buyer or Supplier reasonably determines that a recall is advisable because the goods may create a potential safety hazard, are not in compliance with any applicable code, standard or legal requirement, or contain a defect or non-conformance with the requirements of this Order occurring or likely to occur in multiple goods, which such defects or non-conformances are substantially similar or have substantially similar causes or effects (collectively a “Serial Defect”), the parties shall promptly communicate such facts to each other. At Buyer’s request, Supplier shall promptly develop a corrective action plan satisfactory to Buyer, which shall include all actions required to recall and/or repair the goods and any actions required by applicable Law (“Corrective Action Plan”) for Buyer’s review and approval. At Buyer’s election, Xxxxx may develop the Corrective Action Plan. In no event shall Buyer and Supplier’s failure to agree on the Corrective Action Plan delay the timely notification of a potential safety hazard, non-compliance or Serial Defect to users of the goods, cause either party to be non-compliant with applicable Law or prevent Buyer from taking reasonable actions to prevent injury or damage to persons, equipment or other property. Supplier and Buyer shall cooperate with and assist each other in any corrective actions and/or filings, if applicable.
Clinical Studies The animal and other preclinical studies and clinical trials conducted by the Company or on behalf of the Company were, and, if still pending are, to the Company’s knowledge, being conducted in all material respects in compliance with all Applicable Laws and in accordance with experimental protocols, procedures and controls generally used by qualified experts in the preclinical study and clinical trials of new drugs and biologics as applied to comparable products to those being developed by the Company; the descriptions of the results of such preclinical studies and clinical trials contained in the Registration Statement and the Prospectus are accurate and complete in all material respects, and, except as set forth in the Registration Statement and the Prospectus, the Company has no knowledge of any other clinical trials or preclinical studies, the results of which reasonably call into question the clinical trial or preclinical study results described or referred to in the Registration Statement and the Prospectus when viewed in the context in which such results are described; and the Company has not received any written notices or correspondence from the FDA, the EMA, or any other domestic or foreign governmental agency requiring the termination, suspension or modification of any preclinical studies or clinical trials conducted by or on behalf of the Company that are described in the Registration Statement and the Prospectus or the results of which are referred to in the Registration Statement and the Prospectus.
Product Recalls The Company is not aware of any pattern or series of claims against the Company or any of its subsidiaries which reasonably could be expected to result in a generalized product recall relating to products sold by the Company or any of its subsidiaries, regardless of whether such product recall is formal, informal, voluntary or involuntary.
Targets and Milestones Comparing the relative performance of different groups to the over or under- representation within the institution and taking into account our current performance in our Access Agreement milestones, areas for particular focus include: Low Participating Neighbourhoods; Low income groups; Target groups to include gender, disability and care leavers; Black and minority ethnic (BME) group attainment; Completion rates. As a result of the analysis of our performances, our access, success and progression interventions will concentrate on the following: Continuation of involvement in collaborative outreach activity via the KMPF and the Kent and Medway Collaborative Network (KMCNet) as part of the National Network for Collaborative Outreach (NNCO); Recognition of the importance of carefully targeted activity; The use of serial rather than one-off interventions; The importance of long-term outreach to include the whole student lifecycle; The helpfulness of Higher Education Access Tracker (HEAT) for evaluating the impact of interventions; The importance of a whole institution approach; The importance of student attendance monitoring; Ease of access to information and student welfare support; An increasing emphasis on evaluation of activities across the student lifecycle; Accessibility of employability advice and support. Given our relatively strong record to date for widening access and student success, most of the targets seek to maintain, and where possible improve, this performance within a more challenging financial environment. Such targets may be especially challenging and stretching in relation to the access of those from Low Participating Neighbourhoods (LPNs), given the demographic decline in the number of young people (aged 18-21) in the population and the University’s already high recruitment levels from these groups. We have removed the University’s NS-SEC target in response to the UK Performance Indicator Steering Group announcement that HESA will no longer be publishing the NS-SEC indicator after 2016. As we already have LPN and Household Income targets in place we shall not be replacing this target with an alternative. We have reviewed our success targets and added new progression targets for 2017. There was a concern in the institution that our internal reporting did not allow for national and regionally adjusted benchmark comparison. We have therefore made the following adjustments to our success targets: Non-continuation two years following year of entry: part-time first degree entrants – all entrants: Replacing the OFFA agreement target with the similar data from HESA allows for national benchmarking to be undertaken in order to ensure that the University is maintaining its commitment to these students. We aim to keep our non-continuation rate in this area below our HESA benchmark rate. Non-continuation following year of entry: UK domiciled full-time first degree entrants – mature entrants: Changing the target to clearly focus on mature full-time first degree students (to match the national HESA data) ensures that we focus our efforts on this section of the student population and for the outcomes to be compared with HESA benchmarks rather than internally produced data. We aim to ensure that this student population’s non-continuation rate is at or below the HESA benchmark rate by 2020/21. Non-continuation following year of entry: UK domiciled full-time first degree entrants – all entrants: In order to ensure that young students are not disadvantaged by the focus on mature entrants, the University will also commit to maintaining the overall non-continuation rate for all students at or below the HESA benchmark. BME: the University will replace the current phrasing of the target around BME success with a more explicit aim of reducing the success gap experienced by BME students. Progression: the University has added a progression target that aims to keep us around or above the sector benchmark for the Employment Indicator from the DLHE survey. Combined targets from the collaborative KMPF project (agreed by all partners) are to raise applications and subsequent conversions to higher education from within the target schools and colleges in LPNs. These targets will need to be reviewed in the coming years to reflect changes to GCSE grading in schools. Our institutional and collaborative targets are included in tables 7a and 7b respectively.
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.
Random Drug Testing All employees covered by this Agreement shall be subject to random drug testing in accordance with Appendix D.
Commercialization Intrexon shall have the right to develop and Commercialize the Reverted Products itself or with one or more Third Parties, and shall have the right, without obligation to Fibrocell, to take any such actions in connection with such activities as Intrexon (or its designee), at its discretion, deems appropriate.
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.
