Formulation Development Sample Clauses

POPULAR SAMPLE Copied 4 times
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.
View SourceView Similar (4)
Formulation Development. Coherus shall be responsible for [***] development of Product formulations and performance of stability analyses on such formulations.
View SourceView Similar (3)
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.
View SourceView Similar (3)
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.
View Source
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.
View Source
Formulation Development. Patheon will provide a protocol and report for Formulation Development.
View Source
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).
View Source
Formulation Development. 3 7.1. Vehicle Screening for Liquid Fill Capsules 3 7.2. Liquid Filled Capsules Feasibility Batches 3
View Source
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.
View Source

Related to Formulation Development

  • Program Development NWESD agrees that priority in the development of new applications services by WSIPC shall be in accordance with the expressed direction of the WSIPC 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 As part of their induction, new staff will be made aware of this policy and will be asked to ensure compliance with its procedures at all times.

  • 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.

  • Supplier Development lf the Buyer identifies problems in supplier performance based on supplier monitoring, he shall initiate improvement measures at the Supplier. The Buyer shall pursue the possibilities of continuous improvement of the Supplier. The supplier audit is a form of supplier development; the exchange of information and experience between the Buyer and the Supplier also serves this purpose.