Testing. Landlord shall have the right to conduct annual tests of the Premises to determine whether any contamination of the Premises or the Project has occurred as a result of Tenant’s use. Tenant shall be required to pay the cost of such annual test of the Premises only if there is violation of this Section 30 or if contamination for which Tenant is responsible under this Section 30 is identified; provided, however, that if Tenant conducts its own tests of the Premises using third party contractors and test procedures acceptable to Landlord which tests are certified to Landlord, Landlord shall accept such

“Manufacture” and “Manufacturing” means any steps, processes and activities necessary to produce Product including the manufacturing, processing, packaging, labeling, quality control testing, stability testing, release, storage or supply of Product.

“Manufacture” shall mean all activities related to the manufacturing of a pharmaceutical product, or any ingredient thereof, including but not limited to test method development and stability testing, formulation, process development, manufacturing for use in non-clinical or clinical studies, manufacturing scale-up, manufacturing Licensed Compound or Licensed Product quality assurance/quality control development, quality control testing (including in-process release and stability testing), packaging, release of product or any component or ingredient thereof, quality assurance activities related to manufacturing and release of product, and regulatory activities related to all of the foregoing.

Specifications; Testing. For Work Orders for GMP Manufacturing, WuXi ATU shall Manufacture Product in accordance with the Batch Records and assess (through testing and Batch record review) whether such Product conforms to the Specifications established for such Product and as set forth in the applicable Work Order.

Product Testing. TRIS shall conduct, or cause to be conducted, all physical parameters and in-process testing with respect to each batch of a Product to be supplied pursuant hereto prior to delivery thereof to AYTU. Prior to release to AYTU, TRIS shall perform quality control testing at its own expense on representative samples of each batch of Product to determine/verify it meets Product Specifications. TRIS will provide AYTU with each shipment of Product, a Certificate of Analysis certifying the Product has met Product Specifications. TRIS shall retain a sample of each batch tested for at least the shelf life of such batch, or such longer period as may be required by cGMP.

Inspection/Testing. In order to assess Seller’s work quality, conformance with Buyer’s specifications and compliance with this Order, including but not limited to Seller’s representations, warranties, certifications and covenants under this Order, upon reasonable notice by Buyer, all: # goods, materials and services related in any way to the goods and services purchased hereunder (including without limitation raw materials, components, intermediate assemblies, work in process, tools and end products) shall be subject to inspection and test by Buyer and its customer or representative at all times and places, including sites where the goods and services arc created or performed, whether they arc al premises of Seller, Seller’s suppliers or elsewhere; and # of Seller’s books and records relating to this Order shall be subject to inspection by Buyer. If any inspection, test, audit or similar oversight activity is made on Seller’s or its suppliers’ premises, Seller shall, without additional charge: # provide al! reasonable access and assistance for the safely and convenience of the inspectors and # take all necessary precautions and implement appropriate safety procedures for the safety of Buyer’s personnel while they are present on such premises. If Buyer’s personnel require medical attention on such premises, Seller will arrange for appropriate attention, If in Buyer’s opinion the safety of its personnel on such premises may be imperiled by local conditions, Buyer may remove some or all of its personnel from such premises, and Buyer shall have no responsibility for any resulting impact on Seller or its suppliers. If specific Buyer and/or Buyer’s customer tests, inspection and/or witness points are included in this Order, the goods shall not be shipped without an inspector’s release or a written waiver of test/inspection/witness with respect to each such point; however, Buyer shall not be permitted to unreasonably delay shipment; and Seller shall notify Buyer in writing at least twenty (20) days prior to each of Seller’s scheduled final and, if applicable, intermediate test/inspection/witness points. Buyer’s failure to inspect, accept, reject or detect defects by inspection shall neither relieve Seller from responsibility for such goods or services that are not in accordance with the Order requirements nor impose liabilities on Buyer.

“Development” or “Develop” - all preclinical development activities and all clinical drug development and regulatory activities regarding Compound or Product. Development shall include, without limitation, all preclinical testing, test method development and stability testing, toxicology, formulation, process development, manufacturing scale-up, qualification and validation, quality assurance/quality control, Clinical Studies, manufacturing clinical supplies, regulatory affairs, statistical analysis and report writing. When used as a verb, “Develop” shall mean to engage in Development.

“Development” means all activities related to research, pre-clinical and other non-clinical testing, test method development and stability testing, toxicology, formulation, process development, manufacturing scale-up, qualification and validation, quality assurance/quality control, Clinical Studies, including Manufacturing in support thereof, statistical analysis and report writing, the preparation and submission of Drug Approval Applications, regulatory affairs with respect to the foregoing and all other activities necessary or reasonably useful or otherwise requested or required by a Regulatory Authority as a condition or in support of obtaining or maintaining a Regulatory Approval. When used as a verb, “Develop” means to CONFIDENTIAL TREATMENT REQUESTED. INFORMATION FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED IS OMITTED AND MARKED WITH “[...​...]”. AN UNREDACTED VERSION OF THE DOCUMENT HAS ALSO BEEN FURNISHED SEPARATELY TO THE SECURITIES AND EXCHANGE COMMISSION AS REQUIRED BY RULE 406 UNDER THE SECURITIES ACT OF 1933, AS AMENDED.

[Section 1.44] (definition of Stability Period) shall be amended in its entirety, to read as follows:

“Interest Coverage Ratio” means, for any Testing Period, the ratio of # Consolidated EBITDA for such Testing Period to # Consolidated Interest Expense for such Testing Period.

“Develop” or “Development” means to engage in research and development activities intended to research, discover or develop Compounds and/or to support INDs, NDAs or other Regulatory Approvals for Products, including, without limitation, # development of the applicable active drug substance(s), # toxicology, pre-clinical and clinical drug development activities, # clinical trials (except for Phase IV Studies), # assay/test method development, validation and stability testing, # formulation development, # manufacture of pre-clinical, clinical and commercial supplies, and manufacturing process development, scale-up and validation, # quality assurance/quality control, statistical analysis, and regulatory affairs (including without limitation the preparation, submission and maintenance of all INDs and NDAs for the Products), and # to have any of the activities described in (i)-(vii) performed.

Antibody stability, aggregation, suitability for manufacture, timelines for manufacture (if not already manufactured), CHO cell titers and analytics (if manufactured)

3.4Independent Testing. If Supplier disagrees with Purchaser’s determination that certain units of Supply Deliverables are Defective Product, then either Party may submit such Supply Deliverables to an independent Third Party testing service, mutually and reasonably acceptable to both parties, for analytical testing to determine whether such Supply Deliverables are Defective Product. The Parties agree that such testing service’s determination shall be final and determinative. The Party against whom the Third Party testing service rules shall bear all costs of the Third Party testing.

“Leverage Ratio” means, for any Testing Period, the ratio of # Consolidated Total Debt as of the last date of such Testing Period to # Consolidated EBITDA for such Testing Period.

such other mortality table, interest rate, lookback period and stability period as may from time to time be prescribed by the Committee,

Records; Audit Rights. [[Organization A:Organization]] shall maintain, and shall cause its agents to maintain, all records necessary to comply with all applicable Laws relating to the production, filling, packaging, testing, storage and shipment of Products. "Laws" means any statute, law, ordinance, regulation, rule, code, order, constitution, treaty, common law, judgment, decree, other requirement or rule of law of any governmental entity, but does not include any United States federal law concerning cannabis, including the Controlled Substances Act, 21 U.S.C. §§ 801, et. seq. All such records shall be maintained for such period as may be required by applicable Laws; provided, however, that all records relating to the production, stability and quality control of Products shall be retained until the parties agree to dispose of such records.

Products have been selected for testing by a Governmental Authority which testing would affect or prevent manufacture or delivery.