Formulation Development Sample Clauses

Formulation Development. During the Term, each Party (the “Developing Party”) may, in its discretion and subject to the licenses granted in Section 2.1, engage a Third Party to develop additional formulations of a Product and such engagement may result in the development of Patents and/or Know-How relating formulations of a Product (“Formulation Technology”). To the extent any Formulation Technology is Controlled by the Developing Party, it will automatically be included in the licenses granted to the other Party under Sections 2.1 or 2.5, as applicable. To the extent any Formulation Technology is not Controlled by the Developing Party and is instead Controlled by a Third Party, upon the request of the other Party, the Developing Party will cooperate and in good faith facilitate negotiations between such Third Party and the other Party to allow the other Party to use and exploit such Formulation Technology in a manner consistent with the rights of such other Party under this Agreement. For clarity, neither Party will pay any additional consideration for rights to Formulation Technology Controlled by a Developing Party.
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Formulation Development. Coherus shall be responsible for [***] development of Product formulations and performance of stability analyses on such formulations.
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Formulation Development. Formulation shall mean a specific combination of Materials that formulate the Active Ingredient, as well as compounds other than the Active Ingredient, developed as a result of the work conducted under the Development Plan. The development of the Formulation of the Product, includes without limitation, all stability tests and other studies as applicable, providing CARDAX reports of such stability tests, using Commercially Reasonable Efforts to modify the Formulation as necessary and develop processes capable of scale-up and commercialization in accordance with Applicable Laws.
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Formulation Development. 4.1 QS Pharma will utilize the current 10 mg tablet formulation composition to make a high shear wet granulation tablet that plans to utilize pregelatinized starch, lactose, magnesium stearate with fluid bed drying. The intent is to move from the paste granulation tablet formulation to a tablet formulation that employs current technology and is manufacturable. The process train is planned to include screens, a blender, high shear granulator, fluid bed dryer and a tablet press. The ultimate scale will dictate the specific processing equipment. The characterization will include a feasibility batch that approximates the CTM batch size. Prior to the commencement of manufacturing, development batch records that specify the manufacturing procedures and acceptance criteria will be prepared by QS Pharma. These batches will be packaged in bulk with a sufficient quantity packaged into HDPE bottles for stability. 4.2 The initial and stability test methods are provided in 3.4. A single time zero analysis will cover all storage conditions. The stability protocol is proposed to include 25ñC/60% RH at 1, 2 and 3 months and 40ñC/75% RH at 1, 2 and 3 months.
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Formulation Development. 3 7.1. Vehicle Screening for Liquid Fill Capsules 3 7.2. Liquid Filled Capsules Feasibility Batches 3
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Formulation Development. Patheon will provide a protocol and report for Formulation Development.
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Formulation Development. Arbutus shall perform process and formulation development with Alexion’s mRNA payload and Alexion shall perform efficacy and tolerability studies in rodents and non-human primates. Details of the formulation development work to be done by Arbutus shall be provided in the Research Plan. Arbutus shall not provide an LNP Formulation that is claimed and Covered by any of the Excluded Arbutus Patents.
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Formulation Development. (a) Arbutus shall perform process and formulation development with Alexion’s mRNA payload and Alexion shall perform efficacy and tolerability studies in rodents and non-human primates. Details of the formulation development work to be done by Arbutus shall be provided in the Research Plan. Arbutus shall not provide an LNP Formulation that is claimed and Covered by any of the Excluded Arbutus Patents. (b) Alexion shall reimburse Arbutus for costs incurred during the formulation development period as follows: (i) materials utilized during the formulation development at cost, (ii) time spent by personnel working on the formulation development at the FTE Rate in accordance with the Research Plan; and (iii) out-of-pocket expenses paid by Arbutus. (c) Arbutus shall not, and shall cause its Affiliates to not, (i) use any mRNA material, including mRNA API and/or payload, provided by or on behalf of Alexion (“mRNA Material”) for any activity other than as set forth in this Agreement, including in the Research Plan; (ii) transfer any mRNA Material to any Person without Alexion’s prior written consent; or (iii) modify, analyze, deconstruct or reverse engineer any mRNA Material to determine the structure, sequence or composition of such mRNA Material (including to develop any Know How or other Intellectual Property directed to or otherwise pertaining to any mRNA Material, including the chemical modification of any mRNA Material embodied by such mRNA Material or details of any polypeptide arising from the expression of any mRNA Material).
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Formulation Development. 2.1 will develop a discriminating dissolution method and will perform dissolution testing of innovator product – up to three (3) lots to use for comparative dissolution screening. 2.2 will provide the formulation for each strength, which is a direct compression. 2.3 will prepare a development protocol and have signed by **** prior to initiating development activities. 2.4 Manufacture of two (2) prototypes- one (1) x **** and one (1) x **** at approximately **** tablets in scale. **** will test for the following: 2.4.1 Dissolution Profile if not provided by Antares 2.4.2 Physical Appearance 2.4.3 Assay and Related Substances 2.4.4 Content Uniformity 2.4.5 Disintegration 2.4.6 Moisture by KF 2.4.7 Blend Uniformity 2.4.8 Bulk / Tap Density 2.4.9 Tablet Compression Characteristics (= Tablet properties? See §2.4.11 here below) 2.4.10 Taste Masking Evaluation to be performed by Antares – development samples will be sent to Antares. Results will be provided to **** within one (1) week of receipt of samples in order to maintain project time lines. 2.4.11 Tablet properties (weight variation, hardness, thickness, friability and disintegration) 2.5 will perform tablet compression studies on the two (2) tablet strengths. 2.6 The **** prototype will be placed on accelerated stability in two (2) package configurations (aclar blisters and foil/foil blisters) at 40°C/75% RH and will be tested at 1, 2 and 3 months for dissolution and assay and related substances, moisture, appearance and tablets properties. (Total two (2) batches on stability – 1 prototype in 2 package configurations) Initial 1 Month 2 Months 3 Months 0-Optional Decision Point 1: ****, Antares and **** will review the one (1) month stability data to **** — Denotes portions omitted pursuant to a request for confidentiality under Rule 24b-2 of the Securities Exchange Act of 1934. A copy of this agreement with the omitted information intact has been filed separately with the Securities and Exchange Commission. Decision Point 2: ****, Antares and **** will review the two (2) month stability data to order the blister tooling (aclar with foil backing or foil/foil). NOTE: **** will package in blister cards with in house tooling for the development batches in aclar and foil/foil . Tooling will have to be ordered immediately once final formulation and tablet weight, thickness confirmed so prototypes can be sent to blister tooling manufacturer.
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Related to Formulation Development

  • Program Development NWESD agrees that priority in the development of new applications services by XXXXX shall be in accordance with the expressed direction of the XXXXX Board of Directors operating under their bylaws.

  • Design Development An interim step in the design process. Design Development documents consist of plans, elevations, and other drawings and outline specifications. These documents will fix and illustrate the size and character of the entire project in its essentials as to kinds of materials, type of structure, grade elevations, sidewalks, utilities, roads, parking areas, mechanical and electrical systems, and such other work as may be required.

  • Staff Development ‌ The County and the Association agree that the County retains full authority to determine training needs, resources that can be made available, and the method of payment for training authorized by the County. Nothing in this subsection shall preclude the right of an employee to request specific training.

  • Curriculum Development This includes the analysis and coordination of textual materials; constant review of current literature in the field, some of which are selected for the college library collection, the preparation of selective, descriptive materials such as outlines and syllabi; conferring with other faculty and administration on curricular problems; and, the attendance and participation in inter and intra-college conferences and advisory committees.

  • Joint Development If joint development is involved, the Recipient agrees to follow the latest edition of FTA Circular 7050.1, “Federal Transit Administration Guidance on Joint Development.”

  • Career Development The City and the Union agree that employee career growth can be beneficial to both the City and the affected employee. As such, consistent with training needs identified by the City and the financial resources appropriated therefore by the City, the City shall provide educational and training opportunities for employee career growth. Each employee shall be responsible for utilizing those training and educational opportunities made available by the City or other institutions for the self- development effort needed to achieve personal career goals.

  • Project Development a. Collaborate with COUNTY and project clients to identify requirements and develop a project Scope Statement. a. Develop a Work Breakdown Structure (WBS) for each project. b. Evaluate Scope Statement to develop a preliminary cost estimate and determinate whether project be vendor bid or be executed under a Job Order Contract (JOC).

  • Product Development (a) Supplier may develop enhancements it intends to incorporate into the BioGlue Surgical Adhesive during the term of this Agreement that have potential application to the Company Product (“Enhancements”). Unless otherwise agreed by the parties, at least once every six months during the Term, representatives of each of BioForm and Supplier shall hold a meeting in accordance with Sections 4.4 and 8.4 (the “Product Development Meeting”) at which Supplier will present Enhancements for BioForm to consider for application to the Company Product. At such Product Development Meeting, BioForm will also present its marketing plans (pursuant to Section 4.4) for the period and any information or feedback that BioForm reasonably believes may lead to Improvements. Within 30 calendar days following each Product Development Meeting, Supplier shall deliver a notice to BioForm (the “Enhancements Notice”) that shall describe the Enhancements that were presented by Supplier at such Product Development Meeting. Within 30 calendar days following receipt of the Enhancements Notice, BioForm may notify Supplier in writing if BioForm elects that any Enhancement described in the Enhancements Notice shall become an Improvement. If BioForm does provide such notice to Supplier during such 30-calendar day period, then BioForm and Supplier shall agree on a timeline for implementation of the Improvement in new Product Specifications for Company Product. If BioForm does not provide such a notice, said Enhancement shall not be implemented into the Company Product. The Enhancements Notice may also describe any potential Enhancements presented by Supplier at the Product Development Meeting, but BioForm shall not be required to take any action under this Section 8.4 with respect to such potential Enhancements until such time as they are presented by Supplier as Enhancements at a future Product Development Meeting. All Enhancements and potential Enhancement information provided by Supplier shall be considered Supplier Confidential Information. (b) From time to time, each party may request the other party to participate in joint projects to develop Improvements. Neither party is obligated to participate in such projects, and in each **** Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. instance, each party’s decision whether to participate will be made in such party’s sole discretion. If both parties mutually agree to participate in such a project (a “Program”), the parties will promptly prepare a mutually agreeable written development agreement specifying the development activities to be performed by and the research and development tasks assigned to each party (the “Development Agreement”). All allocation of Intellectual Property rights with respect to any Program will be set forth in writing in the Development Agreement. (c) In the absence of a Development Agreement, (i) BioForm and Supplier shall retain joint ownership of Intellectual Property rights in which there is joint inventorship by BioForm (or its Affiliates) and Supplier, as determined in accordance with United States patent law, with Supplier’s rights in such joint ownership being subject to the license rights of BioForm under this Agreement, (ii) any Intellectual Property rights related to the Company Products, Enhancements, and Improvements that are created solely by employees or consultants of Supplier during the Term shall be considered to be Intellectual Property rights of Supplier, subject to the license rights of BioForm under this Agreement, and (iii) any Intellectual Property rights related to the Company Products and Improvements that are created solely by employees or consultants of BioForm or any of its Affiliates during the Term shall be considered to be Intellectual Property rights of BioForm. BioForm hereby grants to Supplier a perpetual, royalty free, world-wide, nonexclusive license to Supplier under such Blocking Intellectual Property to make, use, and sell such Intellectual Property outside the Field. “Blocking Intellectual Property” for the purposes of Section 8.4(c)(iii) shall mean Intellectual Property necessary for Supplier to make, use, or sell SA Product.

  • Job Development ‌ a. Does the district conduct or access job development services to expand job opportunities for TA and SNAP participants? Yes No If Yes, select how the district participates in job development activities. District staff contacts employers to solicit jobs for TA and SNAP Participants. Describe below how this is done, including number of staff, frequency of contacts, etc. Self Sufficiency Supervisory Staff members promote the hiring of Temporary Assistance clients through the use of the Transitional Employment Advancement Program (TEAP). MCDSS offers periodic job interviews with 60 - 75 TA recipients (concentrating on the Safety Net Singles) to fill vacant positions with companies who may participate with TEAP or OJT. Daily, job openings are received from area employers and reviewed by the Self Sufficiency staff for possible applicant matching. All jobs are posted in our waiting rooms, handed out at our front windows, given during recertification interviews or employment assessments for clients and applicants to review and submit applications to. To find additional employers, intranet searches of employment web sites, phone calls, cold calls, and mailings are made to employers in the area to explain the TEAP and OJT contracts along with information about Tax Incentives. Self Sufficiency staff also attend Job Fairs, as they arise to speak with employers and discuss the benefits of hiring a client currently on Public Assistance. Individuals that are eligible for TEAP or OJT are also given a TEAP brochure and OJT literature to use to advise potential employers that they are eligible for TEAP or OJT if they are hired. The Employment Coordinator receives notifications of job postings from various Monroe County vendors, we then try to match clients with these positions. MCDSS screens recipients for job skills matching current openings at an employer. MCDSS then schedules recipients to come to office and have a job interview here in the building. We assist with online application filing and interview preparation before the interview is conducted with the employer. MCDSS receives notifications of community job fairs and advises employable individuals to attend. MCDSS is able to have a sign in table at these events and are able to mentor individuals and offer support during the fair. District contracts or has an agreement with another agency to contact employers and solicit jobs for TA and/or SNAP participants. Describe below how this is done, including number of staff, frequency of contacts, etc. RochesterWorks, Inc. - There are 3 full-time staff dedicated to employer outreach on the RochesterWorks Business Services team. Outreach is done on a daily basis in a variety of ways such as through daily job posts on behalf of business, presentations to business/industry associations and groups like the local Xxxxxxxx of Commerce, Pro-ROC (Professional Recruiters of Rochester) and other networks; one-on-one meetings at employers’ worksites, virtually, over the phone or via email; virtual and in-person recruitment events; and monthly business newsletters. RochesterWorks also engages employers referred by our local county Economic Development Department as well as the Department of Labor, to promote and connect job seekers with hiring companies. In addition to free job posting, recruitment events, and promotion, RochesterWorks offers work-based training grants in the form of On-the-Job Training (partial wage subsidy) and Transitional Jobs (fully subsidized). Career Systems currently refers Job Seekers from a number of programs to area job fairs. They will continue this and consider a referral to a job fair to be equivalent to a referral to potential employment; it will be a condition of continued eligibility for the program. They will facilitate, monitor and report this attendance and participation. Career Systems will also develop relationships with hiring agencies that will allow groups of participants to be interviews at the job site. Career Systems staff will facilitate, monitor and report attendance at these functions.

  • Development Within twenty (20) Working Days after the Commencement Date and in accordance with paragraphs 3.10 to 3.12 (Amendment and Revision), the Contractor will prepare and deliver to the Authority for approval the full and final Security Plan which will be based on the draft Security Plan set out in Appendix B.

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