Common use of Material inventory Clause in Contracts

Material inventory. The following table displays the material inventory required for this stability study : Storage condition Control time points Reserve sample Total number Short term + 5°C [*] [*] [*] Witness sample Below - 25°C [*] [*] [*] Initial NA [*] [*] [*] [*] This study will require [*] HDPE bottles containing [*] mg of powder. A total quantity of [*] g of peptide powder is requested for this stability study * Confidential Treatment Requested by the Registrant. Redacted Portion Filed Separately with the Commission Exhibit D Batch Analysis of BA058 API Test Specification Appearance White to off-white powder Identification: HPLC Co-Elutes with reference Identification: TLC Single spot with Rf similar to reference Assay Peptide content (HPLC) Peptide content (HPLC, anhydrous, free base basis) > [*] (w/w) [*] to [*]% Purity BA058 (HPLC) Total related impurities Individual related impurities > [*]%, area % < [*]% < [*]% area % Purity by Mass Spectrometry 44117D(3-34 analog) 44116D (4-34 analog) Not detected** Not detected Acetate Content < [*]% (w/w) Water Content < [*] % (w/w) TFA Content Report Specific Optical Rotation (anhydrous free base corrected) Report Residual Solvents Methanol <[*]% w/w Acetonitrile <[*]% w/w Ethyl Acetate <[*]% w/w Triisopropylsilane <[*]% w/w Dimethylformamid <[*]% w/w Microbial content Bacteria Yeasts and Molds LAL Report (cfu/g) Report (cfu/g) < [*]UI/mg * Confidential Treatment Requested by the Registrant. Redacted Portion Filed Separately with the Commission

Appears in 2 contracts

Samples: Radius Health, Inc., Radius Health, Inc.

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Material inventory. The following table displays the material inventory required for this stability study : Storage condition Control time points Reserve sample Total number Short Long term + 5- 20°C [*] [*] [*] Witness sample Below - 25°C [*] [*] [*] 7 4 11 Initial NA [*] [*] [*] [*] 1 — 1 This study will require [*] 19 HDPE bottles containing [*] 200 mg of powder. A total quantity of [*] 4.1g of peptide powder is requested for this stability study * Confidential Treatment Requested by the Registrant. Redacted Portion Filed Separately with the Commission Exhibit D Batch Analysis of BA058 API Test Specification Appearance White to off-white powder Identification: HPLC Co-Elutes with reference Identification: TLC Single spot with Rf similar to reference Assay Peptide content (HPLC) Peptide content (HPLC, anhydrous, free base basis) > [*] (w/w) [*] to [*]% Purity BA058 (HPLC) Total related impurities Individual related impurities > [*]97.0%, area % < [*]3.0% < [*]1.0% area % Purity by Mass Spectrometry 44117D(3-34 analog) 44116D (4-34 analog) Not detected** Not detected Acetate Content < [*]% (w/w) Water Content < [*] % (w/w) TFA Content Report Specific Optical Rotation (anhydrous free base corrected) Report Residual Solvents Methanol <[*]% w/w Acetonitrile <[*]% w/w Ethyl Acetate <[*]% w/w Triisopropylsilane <[*]% w/w Dimethylformamid <[*]% w/w Microbial content Bacteria Yeasts and Molds LAL Report (cfu/g) Report (cfu/g) < [*]UI/mg * Confidential Treatment Requested by the Registrant. Redacted Portion Filed Separately with the Commission

Appears in 2 contracts

Samples: Radius Health, Inc., Radius Health, Inc.

Material inventory. The following table displays the material inventory required for this stability study : Storage condition Control time points Reserve sample Total number Short Long term + 5- 20°C [*] [*] [*] Witness sample Below - 25°C [*] [*] [*] 7 4 11 Initial NA [*] [*] [*] [*] 1 — 1 This study will require [*] 19 HDPE bottles containing [*] 200 mg of powder. A total quantity of [*] 4.1g of peptide powder is requested for this stability study * Confidential Treatment Requested by the Registrant. Redacted Portion Filed Separately with the Commission Exhibit D Batch Analysis of BA058 API Test Specification Appearance White to off-white powder Identification: HPLC Co-Elutes with reference Identification: TLC Single spot with Rf similar to reference Assay Peptide content (HPLC) Peptide content (HPLC, anhydrous, free base basis) > [*] (w/w) [*] to [*]% Purity BA058 (HPLC) Total related impurities Individual related impurities > [*]97.0%, area % < [*]3.0% < [*]1.0% area % Purity by Mass Spectrometry 44117D(3-34 analog) 44116D (4-34 analog) Not detected** Not detected Acetate Content < [*]% (w/w) Water Content < [*] % (w/w) TFA Content Report Specific Optical Rotation (anhydrous free base corrected) Report Residual Solvents Methanol <[*]% w/w Acetonitrile <[*]% w/w Ethyl Acetate <[*]% w/w Triisopropylsilane <[*]% w/w Dimethylformamid <[*]% w/w Microbial content Bacteria Yeasts and Molds LAL Report (cfu/g) Report (cfu/g) < [*]UI/mg * Confidential Treatment Requested by the Registrant. Redacted Portion Filed Separately with the CommissionCommission AMENDMENT NO.3 to WORK ORDER NO.2* This Amendment No. 3 to Work Order No.2 is entered into on December 15, 2010 by and between Radius Health Inc., a Delaware Corporation, with its principal office at 000 Xxxxxxxxxx Xxxxxx - 5th floor, Xxxxxxxxx, XX 00000, Xxxxxx Xxxxxx of America (“RADIUS”), and LONZA Sales Ltd, a Swiss company having an address at Xxxxxxxxxxxxxxxxxxxxxx 00, XX-0000 Xxxxx, Xxxxxxxxxxx (together with its Affiliates, “Manufacturer”), and upon execution will be incorporated into Development and Manufacturing Services Agreement between RADIUS and Manufacturer dated October 16, 2007 (the “Agreement”). Capitalized terms in this Amendment will have the same meanings as set forth in the Agreement.

Appears in 1 contract

Samples: Development and Manufacturing Services Agreement (Radius Health, Inc.)

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Material inventory. The following table displays the material inventory required for this stability study : Storage condition Control time Reserve condition points Reserve sample Total number Short Long term + 5- 20°C [*] [*] [*] Witness sample Below - 25°C [*] [*] [*] 7 4 11 Initial NA [*] [*] [*] [*] 1 — 1 This study will require [*] 19 HDPE bottles containing [*] 200 mg of powder. A total quantity of [*] 4.1 g of peptide powder is requested for this stability study * Confidential Treatment Requested by the Registrant. Redacted Portion Filed Separately with the Commission Exhibit D Batch Analysis of BA058 API Test Specification Appearance White to off-white powder Identification: HPLC Co-Elutes with reference Identification: TLC Single spot with Rf similar to reference Assay Peptide content (HPLC) Peptide content (HPLC, anhydrous, free base basis) > [*] 78% (w/w) [*] 95 to [*]105% Purity BA058 (HPLC) Total related impurities Individual related impurities > [*]%, area 97.0% ,area% < [*]3.0% < [*]<1.0% area % area% Purity by Mass Spectrometry 44117D(3-34 analog) 44116D (4-34 analog) Not detected** Not detected Acetate Content < [*]15.0% (w/w) Water Content < [*] 10.0% (w/w) TFA Content Report Specific Optical Rotation (anhydrous free base corrected) Report Residual Solvents Methanol <[*]% w0.05%w/w Acetonitrile <[*]0.025% w/w Ethyl Acetate <[*]0.025% w/w Triisopropylsilane <[*]0.010% w/w Dimethylformamid <[*]0.0025% w/w Microbial content Bacteria Yeasts and Molds LAL Report (cfu/g) Report (cfu/g) < [*]7 UI/mg * Confidential Treatment Requested by the Registrant. Redacted Portion Filed Separately with the Commissionmg

Appears in 1 contract

Samples: Radius Health, Inc.

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