Tests and Preclinical and Clinical Trials The preclinical studies and clinical trials conducted by or, to the Company’s knowledge, on behalf of the Company, that are described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, as applicable, and are intended to be submitted to the U.S. Food and Drug Administration (the “FDA”) or other comparable government entities, were and, if still ongoing, are being conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all Authorizations and Applicable Laws, including, without limitation, current Good Clinical Practices and Good Laboratory Practices and any applicable rules and regulations of the jurisdiction in which such trials and studies are being conducted; the descriptions of the results of such studies and trials contained in the Registration Statement, the Pricing Disclosure Package and the Prospectus are, to the Company’s knowledge, accurate and complete in all material respects and fairly present the data derived from such studies and trials; except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the Company is not aware of any studies or trials, the results of which the Company believes reasonably call into question the study or trial results described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus when viewed in the context in which such results are described and the clinical stage of development; and, except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package or the Prospectus, the Company has not received any written notices or written correspondence from the FDA or any governmental entity requiring the termination or suspension of any preclinical studies or clinical trials conducted by or on behalf of the Company, other than ordinary course communications with respect to modifications in connection with the design and implementation of such trials, copies of which communications have been made available to you.
Clinical Trials The studies, tests and preclinical and clinical trials conducted by or on behalf of, or sponsored by, the Company, or in which the Company has participated, that are described in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, or the results of which are referred to in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, were and, if still pending, are being conducted in all material respects in accordance with protocols, procedures and controls pursuant to, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company and all applicable statutes, rules and regulations of the FDA, the EMEA, Health Canada and other comparable drug and medical device (including diagnostic product) regulatory agencies outside of the United States to which they are subject; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus do not contain any misstatement of a material fact or omit a material fact necessary to make such statements not misleading; the Company has no knowledge of any studies, tests or trials not described in the Disclosure Package and the Prospectus the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Registration Statement, the Time of Sale Disclosure Package or Prospectus; and the Company has not received any notices or other correspondence from the FDA, EMEA, Health Canada or any other foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority requiring or threatening the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of, or sponsored by, the Company or in which the Company has participated, and, to the Company’s knowledge, there are no reasonable grounds for the same. Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package and the Prospectus, there has not been any violation of law or regulation by the Company in its respective product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement action.
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.
Commercialization License Subject to the terms of this Agreement, including without limitation Section 2.2 and Theravance's Co-Promotion rights in Section 5.3.2, Theravance hereby grants to GSK, and GSK accepts, an exclusive license under the Theravance Patents and Theravance Know-How to make, have made, use, sell, offer for sale and import Alliance Products in the Territory.
Commercialization Plan (a) Not later than three [***] after submission of Regulatory Filings for each Product in each country of the Territory, Licensee will provide to the JCC for review its initial Commercialization Plan for each Product for each country in the Territory. Such initial Commercialization Plan will describe Licensee’s plans for activities to be conducted for such Product for such country. Each Commercialization Plan shall include the details of obligations to be performed by Licensee to achieve the specific activities that are applicable to the stage of [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. Commercialization (e.g., pre-launch, launch planning, launch, or post-launch) of the applicable Product during the time period covered by such Commercialization Plan and subsequent time periods.
(b) Prior to the First Commercial Sale for such Product in such country, Licensee will provide to the JCC for review an updated Commercialization Plan for such Product for such country. Such updated Commercialization Plan will include, but not be limited to, Licensee’s updated plans for activities to be conducted for such Product for such country prior to launch as well as activities to be conducted in connection with such launch.
(c) Promptly after each anniversary of the First Commercial Sale of such Product during the Term, Licensee will provide to the JCC for review updated Commercialization Plans for such Product for such country. Such further updated Commercialization Plan will include, but not be limited to, Licensee’s plans for Commercialization activities for such Product and such country for the twelve (12) month period following the date of delivery of such Commercialization Plan. No Commercialization Plan may be implemented by Licensee if [***]. Each Commercialization Plan shall be consistent with and shall not contradict the terms of this Agreement [***], and in the event of any inconsistency between the Commercialization Plan and this Agreement, the terms of this Agreement shall prevail. Notwithstanding the foregoing, if a [***], Licensee shall [***] and shall promptly [***].
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.
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.
Clinical 1.1 Provides comprehensive evidence based nursing care and individual case management to a specific group of patients/clients including assessment, intervention and evaluation.
1.2 Undertakes clinical shifts at the direction of senior staff and the Nursing Director including participation on the on-call/after-hours/weekend roster if required.
1.3 Responsible and accountable for patient safety and quality of care through planning, coordinating, performing, facilitating, and evaluating the delivery of patient care relating to a particular group of patients, clients or staff in the practice setting.
1.4 Monitors, reviews and reports upon the standard of nursing practice to ensure that colleagues are working within the scope of nursing practice, following appropriate clinical pathways, policies, procedures and adopting a risk management approach in patient care delivery.
1.5 Participates in xxxx rounds/case conferences as appropriate.
1.6 Educates patients/carers in post discharge management and organises discharge summaries/referrals to other services, as appropriate.
1.7 Supports and liaises with patients, carers, colleagues, medical, nursing, allied health, support staff, external agencies and the private sector to provide coordinated multidisciplinary care.
1.8 Completes clinical documentation and undertakes other administrative/management tasks as required.
1.9 Participates in departmental and other meetings as required to meet organisational and service objectives.
1.10 Develops and seeks to implement change utilising expert clinical knowledge through research and evidence based best practice.
1.11 Monitors and maintains availability of consumable stock.
1.12 Complies with and demonstrates a positive commitment to Regulations, Acts and Policies relevant to nursing including the Code of Ethics for Nurses in Australia, the Code of Conduct for Nurses in Australia, the National Competency Standards for the Registered Nurse and the Poisons Act 2014 and Medicines and Poisons Regulations 2016.
1.13 Promotes and participates in team building and decision making.
1.14 Responsible for the clinical supervision of nurses at Level 1 and/or Enrolled Nurses/ Assistants in Nursing under their supervision.
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 and Commercialization Subject to Sections 4.6 and 4.7, Fibrocell shall be solely responsible for the development and Commercialization of Fibrocell Products and Improved Products. Fibrocell shall be responsible for all costs incurred in connection with the Fibroblast Program except that Intrexon shall be responsible for the following: (a) costs of establishing manufacturing capabilities and facilities in connection with Intrexon’s manufacturing obligation under Section 4.6 (provided, however, that Intrexon may include an allocable portion of such costs, through depreciation and amortization, when calculating the Fully Loaded Cost of manufacturing a Fibrocell Product, to the extent such allocation, depreciation, and amortization is permitted by US GAAP, it being recognized that the majority of non-facilities scale-up costs cannot be capitalized and amortized under US GAAP); (b) costs of basic research with respect to the Intrexon Channel Technology and Intrexon Materials (i.e., platform improvements) but, for clarity, excluding research described in Section 4.7 or research requested by the JSC for the development of a Fibrocell Product or an Improved Product (which research costs shall be reimbursed by Fibrocell); (c) [*****]; and (d) costs of filing, prosecution and maintenance of Intrexon Patents. The costs encompassed within subsection (a) above shall include the scale-up of Intrexon Materials and related active pharmaceutical ingredients for clinical trials and Commercialization of Fibrocell Products undertaken pursuant to Section 4.6, which shall be at Intrexon’s cost whether it elects to conduct such efforts internally or through Third Party contractors retained by either Intrexon or Fibrocell (with Intrexon’s consent).
