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Expiry Dating for Reagents and Solutions in Laboratories: What are FDA's Expectations?

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The FDA has published a Q&A document entitled "How does the FDA interpret the regulations (21 CFR Part 211) regarding the establishment of expiry dating for chemicals, reagents, solutions, and solvents?" - including mobile phases.

"Reagents, and standard solutions" - referenced in cGMP's paragraph 211.194 - are actually meant, including laboratory chemicals like solvents and mobile phases, dry chemicals like salts or primary standards and solutions like buffers, acids and bases, whether purchased or self-prepared in the laboratory.

If the manufacturer suggests an expiry date, that date should be followed. The FDA expects an assessment to be performed for purchased laboratory reagents without expiry date indicated by the manufacturer. For example, literature review of that specific chemical's or chemical family's stability may be acceptable to determine an appropriate "use by" or expiry date.

For in-house prepared solutions (like as mobile phases or other non-quantitative solutions), the FDA expects an assessment to be carried out, too.

However, the FDA requires formal stability studies to be performed to determine an appropriate expiry for in-house prepared solutions used for quantitative analysis in assay or impurity testing. According to ICH Q2B, stability of analytical solutions is a typical method variation that should be assessed during "Robustness testings" during validation of an analytical method.

The resulting "use by" or expiry dates should be documented according to an internal SOP.

These requirements also apply for API manufacturers (APIs according to ICH Q7) and their laboratories.

FDA Compliance Officer Brian Belz from the Office of Manufacturing and Product Quality is named as contact person for further information.

Please see the complete Q&A document for further information.

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Extend or renew Microsoft Entra role assignments in Privileged Identity Management

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Microsoft Entra Privileged Identity Management (PIM) provides controls to manage the access and assignment lifecycle for roles in Microsoft Entra ID. Administrators can assign roles using start and end date-time properties. When the assignment end approaches, Privileged Identity Management sends email notifications to the affected users or groups. It also sends email notifications to Microsoft Entra administrators to ensure that appropriate access is maintained. Assignments might be renewed and remain visible in an expired state for up to 30 days, even if access is not extended.

Who can extend and renew?

Only Global Administrators or Privileged Role administrators can extend or renew Microsoft Entra role assignments. The affected user or group can ask to extend roles that are about to expire and request to renew roles that are already expired.

When are notifications sent?

Privileged Identity Management sends email notifications to administrators and affected user or groups of roles that are expiring within 14 days and one day prior to expiration. It sends another email when an assignment officially expires.

Administrators receive notifications when a user or group assigned an expiring or expired role requests to extend or renew. When an administrator resolves a request as approved or denied, all other administrators are notified of the decision. Then the requesting user or group is notified of the decision.

Extend role assignments

The following steps outline the process for requesting, resolving, or administering an extension or renewal of a role assignment.

Self-extend expiring assignments

Users assigned to a role can extend expiring role assignments directly from the Eligible or Active tab on the My roles page, either under Microsoft Entra roles or from the top level My roles page of the Privileged Identity Management portal. In the portal, users can request to extend eligible or active (assigned) roles that expire in the next 14 days.

When the assignment end date and time is within 14 days, the button to Extend becomes an active link in the user interface. In the following example, assume the current date is March 27.

For a group assigned to a role, the Extend link never becomes available so that a user with an inherited assignment can't extend the group assignment.

To request an extension of this role assignment, select Extend to open the request form.

Enter a reason for the extension request, and then select Extend .

We recommend including the details of why the extension is necessary, and for how long the extension should be granted (if you have this information).

Administrators receive an email notification to review the extension request. If a request to extend has already been submitted, an Azure notification appears in the portal.

Go to the Pending requests page to view the status of your request or to cancel it.

Admin approved extension

When a user or group submits a request to extend a role assignment, administrators receive an email notification that contains the details of the original assignment and the reason for the request. The notification includes a direct link to the request for the administrator to approve or deny.

In addition to using following the link from email, administrators can approve or deny requests by going to the Privileged Identity Management administration portal and selecting Approve requests in the left pane.

When an Administrator selects Approve or Deny , the details of the request are shown, along with a field to provide a business justification for the audit logs.

When approving a request to extend role assignment, administrators can choose a new start date, end date, and assignment type. Changing assignment type might be necessary if the administrator wants to provide limited access to complete a specific task (one day, for example). In this example, the administrator can change the assignment from Eligible to Active . This means they can provide access to the requestor without requiring them to activate.

Admin initiated extension

If a user assigned to a role doesn't request an extension for the role assignment, an administrator can extend an assignment on behalf of the user. Administrative extensions of role assignment do not require approval, but notifications are sent to all other administrators after the role has been extended.

To extend a role assignment, browse to the role or assignment view in Privileged Identity Management. Find the assignment that requires an extension. Then select Extend in the action column.

Extend role assignments using Microsoft Graph API

In the following request, an administrator extends an active assignment using Microsoft Graph API.

HTTP request

Http response, renew role assignments.

While conceptually similar to the process for requesting an extension, the process to renew an expired role assignment is different. Using the following steps, assignments and administrators can renew access to expired roles when necessary.

Users who can no longer access resources can access up to 30 days of expired assignment history. To do this, they browse to My Roles in the left pane, and then select the Expired roles tab in the Microsoft Entra roles section.

The list of roles shown defaults to Eligible roles . Select Eligible or Active assigned roles.

To request renewal for any of the role assignments in the list, select the Renew action. Then provide a reason for the request. It's helpful to provide a duration in addition to any additional context or a business justification that can help the administrator decide whether to approve or deny.

After the request has been submitted, administrators are notified of a pending request to renew a role assignment.

Admin approves

Microsoft Entra administrators can access the renewal request from the link in the email notification, or by accessing Privileged Identity Management from the Microsoft Entra admin center and selecting Approve requests in PIM.

When an administrator selects Approve or Deny , the details of the request are shown along with a field to provide a business justification for the audit logs.

When approving a request to renew role assignment, administrators must enter a new start date, end date, and assignment type.

Admin renew

They can also renew expired role assignments from within the Expired roles tab of a Microsoft Entra role. To view a list of all expired role assignments, on the Assignments screen, select Expired roles .

• Approve or deny requests for Microsoft Entra roles in Privileged Identity Management
• Configure Microsoft Entra role settings in Privileged Identity Management

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What Is Expiration Time?

Understanding expiration time, derivatives contract expiration, caveats at expiration, example: spxw weekly options.

• Options and Derivatives
• Strategy & Education

Expiration Time Explained: What It Is, How It Works, Example

Pete Rathburn is a copy editor and fact-checker with expertise in economics and personal finance and over twenty years of experience in the classroom.

The expiration time of an options contract or other derivative is the exact date and time when it is rendered null and void. Derivatives contracts that finish out of the money (OTM) at the time of expiration will become worthless, while in-the-money (ITM) contracts will be evaluated based on the settlement price upon expiry.

The expiration time is more specific than the expiration date and should not be confused with the last time to trade that option.

Key Takeaways

• The expiration time is the precise date and time at which derivatives contracts cease to trade and any obligations or rights come due or expire.
• Typically, the last day to trade an option is the third Friday of the expiration month.
• Derivative contracts will specify the exact expiration date and time.

Expiration time differs from the expiration date in that the former is when the option actually expires while the latter is the deadline for the holder of the option to make their intentions known. Most option traders need only be concerned with the expiration date but it is useful to know the expiration time as well.

According to NASDAQ , the expiration time is:

The time of day by which all exercise notices must be received on the expiration date. Technically, the expiration time is currently 11:59 a.m. [Eastern Time] on the expiration date, but public holders of option contracts must indicate their desire to exercise no later than 5:30 p.m. [Eastern Time] on the business day preceding the expiration date.

Since many public holders of options deal with brokers , they face different expiration times. In the U.S., the last day to trade an option is typically the third Friday of the expiration month, while the expiration date is the Saturday immediately afterwards. If Friday is a public holiday, the last trading day with be on Thursday.

A public holder of an option usually must declare their notice to exercise by 5:30 p.m. on Friday. This time frame will allow the broker to notify the exchange of the holders' intent by the actual expiration time on Saturday.

Notification limits depend on the exchange where the product trades. For example, the Chicago Board Options Exchange  (CBOE) limits trading on expiring options to 3:00 p.m. Central Time on the last trading day.

An expiration date in derivatives  is the last day that an options or futures contract is valid. When investors buy options, the contracts give them the right, but not the obligation, to buy or sell the assets at a predetermined price, known as the  strike price .

The exercising of the option must be within a given period, which is on or before the expiration date. If an investor chooses not to exercise that right, the option expires and becomes worthless, and the investor loses the money paid to buy it.

The expiration date for listed stock options in the United States is usually the third Friday of the contract month, which is the month when the contract expires. However, when that Friday falls on a holiday, the expiration date is on the Thursday immediately before the third Friday. Once an options or futures contract passes the expiration date , the contract is invalid. The last day to trade equity options is the Friday before expiry.

While the majority of options never reach their expiration dates due to traders offsetting or closing their positions before that time, some options do live on until their actual expiration times. This delay can create interesting dynamics because the last time for trading can be before the expiration time.

This time difference is not a problem when the underlying security also closes for trading at the same time. However, if the underlying security does trade beyond the close of trading for the option, both buyers and sellers might find that the exercise of their contract is automatic if they were ITM . Conversely, they may expect the automatic exercise, but after-hours trading in the underlying asset may push them OTM .

Rules covering these possibilities, especially at what time the final price of the underlying is recorded, can change. So, traders should check with both the exchange where their options trade, as well as the brokerage handling their account.

SPXW are weekly expiration cycle options on the S&P 500 Index listed by the CBOE. SPXW Weeklys are settled on the last trading day, typically a Friday for SPXW EOW Weeklys.

As with other afternoon-settled index options, the exercise-settlement value is calculated using the last (closing) reported sales price in the primary market of each component stock. On the last trading day, trading in expiring SPXW Weeklys closes at 3:00 p.m. Central Standard Time (CST). All non-expiring SPXW Weeklys, meanwhile, continue to trade until 3:15 p.m. CST.

NASDAQ. " Expiration Time ."

NASDAQ. " Expiration Date ."

Cboe Exchange, Inc. " Hours & Holidays ."

CME Group. " Understanding Listings and Expirations ."

Cboe Exchange, Inc. " S&P 500 Index Options ," Page 2.

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Validity, Expiration, and Course Renewal Options

When you configure a required course assignment in Oracle Learning, you can specify a validity period when learners are accredited for their completion. The period always has a start date and might have an expiration date.

For example, your organization requires everyone to complete a business ethics course every year by July 31.

You can also automatically renew the learning assignment according to a specified cycle and assignment completion.

You set validity period options for only required learning assignments. They aren't available for voluntary and recommendation learning assignments. The settings in course configurations also apply only to required learning assignments.

Validity Period Start

The validity period is no earlier than the assignment completion date. But it might be later, depending on which of these options you select:

• After completion (default): The validity period starts when the learner completes the learning.
• After due date : The validity period starts no earlier than the assignment due date. If the learner completes the learning before the due date, the validity period starts on the due date. If the learner completes the learning after the due date, the validity period starts on the completion date.

Validity Period Expiration

The expiration option decide whether the validity period ends, ends at the same time for all the learners, or ends according to each learner’s completion date.

Renewal Options

The renewal options work with the validity period expiration to decide when to automatically generate the next learning assignments. Until the start date, only learning administrators can see the next assignments. Learners see them in their current learning on the start date.

Withdrawn Renewal and New Assignments

How Oracle Learning handles new assignments for learning with withdrawn renewals depends on whether completed assignments from the renewal series are expired.

• If the learner's completions are all expired, a new active assignment appears in their current learning. Because their final completion already expired, the renewal series no longer managers this learner.
• If the learner's final completion hasn't expired, a new assignment won't appear in their current learning. That's because the renewal series still manages this learner until their final completion expires.

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Expiration Dates - Questions and Answers

1. Why are expiration dates important for consumers to pay attention to?

Drug expiration dates reflect the time period during which the product is known to remain stable, which means it retains its strength, quality, and purity when it is stored according to its labeled storage conditions.

2. How are expiration dates established?

FDA regulations require drug applicants to provide stability testing data with a proposed expiration date and storage conditions when they submit an application for FDA approval of their drug.  This testing is designed to provide confidence that the product will meet the applicable standards of strength, quality, and purity throughout its shelf-life. The FDA verifies that an applicant’s proposed expiration date is supported by appropriate studies that the applicant has conducted.

For non-application drugs, such as over-the-counter monograph products, the manufacturer must also conduct stability testing to establish an expiration date and storage conditions to meet FDA’s regulations (see 21 CFR 211.166 as well as related sections 211.137 and 211.160) . 

FDA recommends that applicants and manufacturers follow the recommendations in internationally harmonized guidance documents on stability testing such as the International Council on Harmonization guidance documents (ICH) Q1(A-F) and Q5C.

FDA inspections of manufacturing facilities may include an evaluation of the firm’s stability testing program to verify that labeled expiration dates are supported by a scientifically sound study and appropriate data.

3. Can expiration dates be extended?

FDA’s guidance for industry, “ Changes to an Approved NDA or ANDA ” explains that the manufacturer of an approved drug product may extend the expiration date for the drug product based on their own testing and acceptable data in accordance with a protocol approved in the new drug application (NDA) or abbreviated new drug application (ANDA) (see 21 CFR 314.70).  To help alleviate drug shortages, FDA has also approved extensions of expiration dates when data supporting the extension are available.

4. What potential risks are associated with expired drugs?

It’s important to be aware that there are several potential harms that may occur from taking an expired medicine or one that may have degraded because it was not stored according to the labeled conditions. If a drug has degraded, it might not provide the patient with the intended benefit because it has a lower strength than intended. In addition, when a drug degrades it may yield toxic compounds that could cause consumers to experience unintended side effects. Patients with serious and life-threatening diseases may be particularly vulnerable to potential risks from drugs that have not been stored properly.  There are a number of simple steps consumers can take to dispose of expired medications.

5.  Does FDA conduct testing to extend expiration dates?

FDA supports a public health program involving other partners to extend the expiration dates for a limited number of carefully selected drug products. Under the Shelf-Life Extension Program (SLEP) , FDA conducts testing for certain products stored in federal stockpiles in environmentally controlled locations.  (Federal stockpiles are stores of certain drugs that might be needed to prevent or treat diseases or conditions which may occur during a public health emergency.)  SLEP is a fee-for-service program through which the labeled shelf life of certain federally stockpiled products can be extended after select products undergo periodic stability testing conducted by FDA.

Drugs held by consumers may have been stored under varied conditions after entering the market.  As a result, it would be difficult to conduct testing to determine expiration dates that would be meaningful and generally applicable after prolonged periods of storage under different conditions. The appropriate conditions will depend on the drug, but may include considerations regarding temperature, humidity, and exposure to light.

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Sop for assigning manufacturing & expiry date/retesting date.

• The manufacturing date of the intermediate or the product should be assigned on the basis of the date of charging the project. For ex. If the product is charged on 30 June 2020, the manufacturing date should be mentioned as June 2020.
• For mixed batch, the manufacturing date should be the month in which a mixed batch is manufactured.
• For reprocessing batches, the manufacturing date is assigned based on the date of reprocessing/ rework.
• Following are the criteria to assign the expiry date of the drug product/API.
• Schedule P of drugs and cosmetic
• R & D lab recommendation
• Stability Study Data
• Expiry of raw material active
• For local requirements, the shelf life of the product listed in Schedule P of the Drugs and Cosmetic Acts 1940 should be followed.
• For the products that do not appear in “schedule P” the expiry should be assigned on the basis of Stability data.
• For drug intermediates retesting date should be assigned instead of the expiry date. The retesting date should be assigned based on the recommendation of the R&D lab or based on stability studies Conducted on intermediates.
• For Reprocessing / Reworked batches the expiry date is assigned based on the date of expiration of the oldest constituent batch as explained above.

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Manufacture, Retest and Expiry Date Revisited

by RJTimko | Jan 27, 2022 | Knowledge Management

Several years ago, I wrote about the relationships among date of manufacture, in-process hold times and drug product expiration date. Since then, there have been some developments that are worth revisiting.

The corresponding guidelines of EMA (The European Medicines Agency), FDA (United States’ Food and Drug Administration), PMDA (Japanese Pharmaceuticals and Medical Devices Agency) and ICH (International Committee on Harmonization) enable the production of high-quality pharmaceuticals, which fulfil the safety needs of patients. However, the assignment of the manufacturing, expiration and retest dates for drug substances and drug products are frequently encountered areas in the pharmaceutical industry which continues to lack sufficient guidance.

Drug Substance Retest Date

The drug substance retest date is when a material should be re-examined to ensure that it is still suitable for use. The drug substance retest period is the time during which the drug substance is expected to remain within its specification and, therefore, can be used in the manufacture of a given drug product, provided that the drug substance has been stored under the defined conditions. After this period, a batch of drug substance destined for use in the manufacture of a drug product should be retested for compliance with its specification and then immediately used.

The ICH guideline Q1E “Evaluation for Stability Data” provides recommendations on how to use stability data generated in accordance with the principles described in the ICH guideline Q1A(R2) “Stability Testing of New Drug Substances and Products” to determine a drug substance retest date.

The EMA’s questions and answers paper addresses the extension of the retest period of a drug substance with respect to ICH Q7 Section 11.6. The retest date of a specific batch can be extended based on good science and suitable long-term stability data. The retest date is assigned based on the manufacturing date and the retest period. However, it is unclear on how to assign a date of manufacture. In Section 19.8, the expiration and retest dating as defined in Section 11.6 applies to existing (commercially available) drug substances used in clinical trials. Drug substances in the early stage of clinical trials are not required to have an expiration date nor a retest period.

As mentioned in ICH Q7A “Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients,” a drug substance expiration or retest date should be based on an evaluation of data derived from stability studies. Common practice is to use a retest date, not an expiration date (Section 11.6). If the drug substance has an assigned expiration date, the drug substance’s manufacturers expiration date cannot be extended by means of retesting.

If the drug substance is labeled with a retest date, the drug substance can be re-tested, and if retest results are in compliance with the material specification for critical attributes, such as chemical and microbiological content and purity, the batch may be immediately used. Test results must be obtained with pharmacopeial procedures or stability indicating methods, using primary reference standard. Since immediate use is not defined by the FDA, common practice in the industry is to use within thirty (30) days of the retest date. A batch of drug substance can be retested multiple times and a different portion of the batch used after each retest, as long as it continues to comply with the specification.

Under current rule, a new date for retesting beyond thirty (30) days of immediate use should be based on current retest results and supporting real time and/or accelerated stability data. Successive retest periods may not be longer than the original retest period assigned by the manufacturer of the drug substance. The re-test date must relate to the defined storage conditions specified in the label.

The retest date or the expiration date should be listed either on the container or on the Certificate of Analysis (CoA). In general, a retest or expiration date should be specified by month and year. The retest or expiration date of a blended batch of drug substance should be based on the oldest batch in the blend. For biotechnological/biological substances known to be labile, it is more appropriate to establish a shelf-life than a retest period. The same may be true for some antibiotics.

Drug Substance Manufacture Date

Assigning a drug substance date of manufacture is not very clear. Some claim that the formation of the chemical core structure of a drug substance defines the manufacturing date. Others state that the date of the final packaging or the issuance of the CoA should be considered as manufacturing date of the drug substance.

When a drug substance is in pure form, it usually has an established chemical structure, and good chemist can, from the weakest chemical bond of the structure which would get attacked first by external energy like temperature/ heat or light or hydrolytic degradation, predict the stability of the compound. It is important to justify the manufacturing date taking into consideration the underlying chemical nature of the drug substance.

It is generally advisable to assign the manufacturing date of a drug substance to the last crystallization step performed and before any physical treatment. At this stage all physiochemical properties are settled and additionally to other parameters, the stability of the pure drug substance is established and controlled.

If the compound with the chemical structure responsible for the pharmacological activity is not immediately used in drug product manufacture and additional preparatory steps are performed, it should not be considered as drug substance.

Mixing of drug substance with an excipient or other material to aid further processing or enhance stability, i.e., physically treating the drug substance, and then holding it for a period of time before further manipulation, can be potentially considered as a starting point of drug product manufacture.

Drug Product Expiration Date

A pharmaceutical drug formulation is a different from pure drug and when there are more than a drug present in a mixture, it may increase the chances of degradations.

According to the FDA, and as explained in the stability guidelines, the expiration date assigned to a new batch of finished drug should be calculated from not later than the date of release of the batch provided that the date of release does not exceed approximately thirty (30) days from the start of manufacturing. This is understood to mean from the initial date a drug substance, preservative, or anti-oxidant ingredient is added to the batch. If more than thirty (30) days have elapsed between the date of manufacture and date of release of the batch, the expiration date should be calculated from within thirty (30) days of the date of manufacture of the batch, and not the date of release. The EMA note to the guidance on the manufacture of finished dosage forms provides essentially this same recommendation.

The maximum expiration date for drug product should not exceed five (5) years. When more than one (1) lot of drug product with different manufacture dates are packaged together, the expiration date of the complete package must not exceed that of the product batch with the shortest remaining expiration period in the package.

Extension of already manufactured and packaged drug product may be based on the following criteria which includes continuous, controlled real-time stability program that demonstrates the product to be stable to support the extended expiration dating, concurrent testing of the drug product shows little change from the original test data and is within the defined product specifications, and the desired extension is covered within the approved regulatory documentation. Expiration date assignments should be documented and maintained as part of batch or lot record.

Drug Product Manufacture Date

From an understanding of how the drug product expiration date may be determined, it then becomes clear how a date of manufacture of a drug product should be determined. The Date of Manufacture for a given batch of drug product is the date on which processing is initiated; for example, when the drug substance is mixed with or added to other materials.

A potential confounding issue is when a drug substance with known chemical, physical or biological concerns is manipulated with materials to enhance any of these characteristics before further formulation into a suitable dosage form. In these situations, data to demonstrate the stability of such an intermediate mixture is needed to demonstrate suitability for subsequent formulation into the final dosage form should this intermediate mixture be held for any length of time before final processing.

It such an instance, it may be able to justify a date of manufacture, not when the drug substance is first manipulated, but when it is combined with the materials required to produce the finished dosage form.

The dating for a combination of two or more products must be no longer than the dating of the component with the earlier manufacturing date. . The date of manufacture for biological products, other than whole blood and blood components, must be identified in the approved biologics license application. The date should be based on the following considerations such as the potency test or another specific test as described in a biologics license application or supplement to the application, removal from animals or humans, extraction, solution, cessation of growth, final sterile filtration of a bulk solution, manufacture as described in 21CFR Part 610.50, or other specific manufacturing activity as described in a biologics license application or supplement to the biologics license application.

For licensed whole blood and blood components, the date of manufacture must be identified in the approved biologics license application or supplement to the application. The date of manufacture for whole blood and blood components should take into account the following considerations, as applicable, which are the collection date and/or time, irradiation date, the time the red blood cell product was removed from frozen storage for deglycerolization, the time the additive or rejuvenation solution was added, the time the product was entered for washing or removing plasma (if prepared in an open system), as specified in the instructions for use by the blood collection, processing, and storage system approved or cleared for such use by FDA; or as approved by the Director, Center for Biologics Evaluation and Research, in a biologics license application or supplement to the application.

Timko, R. J., “The Relationship among the Date of Manufacture, In-process Hold Times and Drug Product Expiration Date,” September 28 2017, https://www.RhoTauPharma.com, accessed May 10 2021

Huynh-Ba, K (Ed.). “Handbook of Stability Testing in Pharmaceutical Development: Regulations, Methodologies, and Best Practices,” Springer-Verlag New York, 2009

United States Code of Federal Regulations, Title 21 Sections 211.137, Expiration Dating, 211.166, Stability Testing 610.50 Date of Manufacture for Biological Products

Food and Drug Administration Guideline for Submitting Supporting Documentation in Drug Applications for the Manufacture of Drug Substances, February 1987

International Council on Harmonization Guideline Q1A(R2). Stability Testing of New Drug Substances and Products, November 2003.

International Council on Harmonization Guideline Q1E. Evaluation for Stability Data, February 2003.

International Council on Harmonization Guideline Q7 Good Manufacturing Practice for Active Pharmaceutical Ingredients – Questions and Answers, April 2018

International Council on Harmonization Guideline Q7A, Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients. August 2000.

Note for Guidance on Start of Shelf-life of the Finished Dosage Form, CPMP/QWP/07296, EMEA/CVMP/453/01, London, 31May2001

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IMPORTANT UPDATE: Assigned Training Expiration Dates

A new update has been made to assigned training to edit future expiration dates. feb 1, 2022 • knowledge, information.

In December, we released a series of updates  to enhance your experience with Assigned Training. Today, we are happy to announce another enhancement that enables the editing of future expiration dates. 

There are times when an administrator will need to extend the expiration date of an assignment. This could include there not being enough time to complete the assignment, needing to extend the date for specific individuals, or users who simply didn't complete the assignment prior to the expiration date.  

• The expiration date must be in the future
• It must be a fixed date, not a dynamic expiration date selection

Given these two conditions, when you open the assignment for editing, you will now be able to edit the expiration date:

Below is a list of articles that reflect the new Assigned Training functionality:

JUST RELEASED: Enhanced Assignment Functionality

Assigned Training Management Overview

One-Time Training Assignment

Recurring Training Assignments

Calendar Training Assignment

Smart Enrollments vs. Forced Enrollments

Understanding the Look Back Period

Assignment Automated Cleanup

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Investigational Product Expiry Management

Kurt Lumsden, Director, eCDS Client Services at PAREXEL Informatics, discusses the use of interactive response technologies in investigational product expiry management.

Q. How can interactive response technologies enable IP expiry management and removal of ‘use-by’ dates from the label?

A. Investigational product (IP) manufacturing and packaging for clinical trials is costly. Every effort must be made to ensure optimal utilization and reduced waste. One way this can be accomplished is to effectively manage product expiration or retest dates.

Packaging and labeling requirements often vary by jurisdiction, requiring different labels for each country to be affixed to the package. Expiry or retest dating may also vary by jurisdiction.

Interactive response technologies (IRT) have long been used to manage IP expiry. Flexible systems typically allow updating product expiry at the lot level (with an option to update all unallocated kits now or later and by location), for single-panel labels that do not include the expiry date or by lot/kit and location where the expiry dating requires a relabeling campaign.

Expiry updates for countries that accept removal of expiry from the label follow this process:

• Updating one expiry date (per lot, per country) for all kits
• Updating kits by lot
• Updating IP kits at all locations immediately
• Updating all kits of status “available” or “in transit”.

Countries that do not accept removal of expiry date follow the process outlined below:

• Updating multiple expiry dates (per lot, per country)
• Allowing supplies to be placed on “hold” or “quarantined” to prevent ordering/allocation during re-labeling
• Updating by lot/kit number location or lot, quantity, and location (for non-uniquely numbered supplies) as supplies are relabeled
• Allowing multiple users to perform updates (drug-supply manager for depots; monitors or pharmacist for site locations)
• Ensuring that “in-transit” medication is not automatically updated- to allow for relabeling before status is changed to “available”.

There is no mandatory requirement in the United States or Japan to include expiry on the label. In the European Union, the requirement is covered by Annex 13 (1), which states that labels should include: “the period of use (use-by date, expiry date or re-test date as applicable)”, “unless its absence can be justified, e.g., use of a centralized electronic randomization system.”

After consulting with the industry, the European Medicines Agency (EMA) published a reflection paper outlining circumstances in which expiry could be removed from the label barring these conditions (2): • A copy of the QP signed and dated certificate (CofA or CofC) containing the expiry date and available to site staff • IP is only administered by dedicated, qualified trial staff on site and is not retained by the study subject • IRT assigns IP kits that all have an expiry date good through the period between visits for all kits identified by a unique Med ID (or Batch Number for non-uniquely numbered supplies).. in order to avoid the issues with short dated supplies where situation of administering kits with different expiry dates out of ascending expiry order that could cause administration of expired product • Assignment confirmations or notifications are available to site staff in for each allocated kit, and contain information on study subject, unique kit identifier or Med ID (where available) and associated expiry date • The IP expiry date is valid beyond the planned administration, with adequate buffer to cover any delay in dosing and account for visit windows (covering last possible day of dosing)

In addition to IP labeling,  packaging and ordering, allocation, and dosing, design considerations should also account for any third-party distributor processes for release and expiry updates, impact on pooled supplies (that may have variable pack life depending on trial design), just in time (JIT) and point of dispatch labeling capabilities, as well as QP considerations. This is especially important when sites are running more than one protocol supported by pooled supplies. Use of smartphone applications that can communicate with the IRT system allow verification of current IP kit expiry from a bar code on the label, as well as the capability to provide IP storage and administration instructions to the user.

IRT systems that support removal of expiry from the IP label have the following characteristics:

• Full end-to-end inventory management capabilities from IP release through returns and destruction
• Flexible country status management (accepting vs. non accepting)
• Ordering based on location needs and visit date windows
• Concurrent, consecutive, and partial allocations with unscheduled resupply availability
• Management of pack life vs. treatment group/dose level and visit window
• Visibility of product expiry and availability of documentation via portal
• Transparency of kit expiry date in reports, notifications, and alerts
• Ability to handle single-dose kits vs. cartons and IP pooling across protocols
• Forecasting and supply simulation to time batch manufacture, labeling, and packaging
• Ability to make changes.

Planning and workflow are essential to allow optimization of IP expiry management for clinical trials. The system configuration needs to be specified in advance but changes in requirements supported (i.e., additional product or countries) can be accommodated. The system should be intuitive and allow for real-time updates of expiry and flexibility to support different label configurations and regulatory requirements.

In conclusion, IRT systems provide an efficient and effective way to manage IP expiry in clinical trials. Keys to success include clear definition of requirements, risk analysis, adequate user training, and compliance monitoring.

References 1. Annex 13 MANUFACTURE OF INVESTIGATIONAL MEDICINAL PRODUCTS, Section 26 (j,) http://ec.europa.eu/health/files/eudralex/vol-4/2009_06_annex13.pdf , accessed Sept. 10, 2014. 2. EMA , Reflection paper on the use of interactive response technologies (interactive voice/web response systems) in clinical trials, with particular emphasis on the removal of expiry dates, EMA/INS/GCP/600788/2011, Section 2.3.1. Conduct of phase I to phase IV clinical trials (December 2013), http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2013/12/WC500158536.pdf , accessed Sept. 10, 2014.

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Answer to Question #310053 in Java | JSP | JSF for Tsundzu

A Retail has name, a List containing Items available in the stock and another List containing sold 

1.2 A Retail have functionality to view available stock, that prints Class name of item, name of Item, 

size of item and total number of items that have same name, and size. [5]

ClassName Item name Size Total

Drink coke 1 10; // this show that in the list there are 10 coke that are size of 1

Drink coke 2 5; // this show that in the list there are 5 coke that are size 2

Sizes in drinks means litres.

Hint: Items are the same if their class name, item name and size are the same.

1.3. A retail Shop has a functionality to add item into the stock list. The add item takes a parameter 

the Item to be added on stock. [2]

1.4 A retail shop also has a functionality to calculate total sales that returns double sum of money 

made from all sold items. [2]

import java.time.Duration;

import java.time.LocalDateTime;

import java.util.*;

public class RetailShop {

public Map<String, Item> stock = new HashMap<>();

public Map<String, Integer> sold = new HashMap<>();

public void sell(String itemName, int itemSize) {

Item itemInStock = stock.get(itemName);

if (itemInStock != null && itemInStock.getAmount() >= itemSize) {

itemInStock.setAmount(itemInStock.getAmount() - itemSize);

sold.merge(itemName, itemSize, Integer::sum);

long daysBeforeExpiry = Duration.between(LocalDateTime.now(), itemInStock.getExpiryDate()).toDays();

System.out.println("Name: " + itemName);

System.out.println("Size: " + itemSize);

System.out.println("Days before expiry date: " + daysBeforeExpiry);

System.out.println("no stock");

public class Item {

private String name;

private double price;

private int amount;

private LocalDateTime expiryDate;

public Item(String name, double price, int amount, LocalDateTime expiryDate) {

this.name = name;

this.price = price;

this.amount = amount;

this.expiryDate = expiryDate;

public int getAmount() {

return amount;

public void setAmount(int amount) {

public double getPrice() {

return price;

public void setPrice(double price) {

public String getName() {

return name;

public void setName(String name) {

public LocalDateTime getExpiryDate() {

return expiryDate;

public void setExpiryDate(LocalDateTime expiryDate) {

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Tip: Add an expiration date to an engagement letter

Bvwire issue #235-3, april 20, 2022.

During a very informative—and entertaining—webinar on expert witnessing, Robert Vance (Forensic & Valuation Services PLC), gave this advice: Consider putting an expiration date on the cover letter to your proposed engagement letter. He has found that certain firms will try to “conflict you out,” meaning they don’t necessarily want to hire you, but they don’t want the other side to hire you. They somehow think that the engagement letter ties up the expert even though it doesn’t get signed. Therefore, Vance uses a 10-day expiration date. He notes that this is especially important if the opposing side is a firm you have worked for before, so the 10-day expiration can clear the way to be hired by the other firm.

Vance gave many other good pieces of advice during his webinar, So You Want to Testify as a Financial Expert Witness? Testimony Tips, Traps, and Video Demonstrations From the Trenches. Click here for a recording (free to holders of BVR’s Training Passport Pro).

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Here's what happens if Trump can't pay his $454 million bond

Andrea Bernstein

Rachel Treisman

Forty Wall Street, a Trump-owned building, stands in downtown Manhattan. Former President Trump says he can't secure a bond to appeal the $454 million penalty in his civil fraud case. But New York Attorney General Letitia James says she is prepared to seize the former president's assets, including the building at 40 Wall Street, if he is unable to pay. Spencer Platt/Getty Images hide caption

Forty Wall Street, a Trump-owned building, stands in downtown Manhattan. Former President Trump says he can't secure a bond to appeal the $454 million penalty in his civil fraud case. But New York Attorney General Letitia James says she is prepared to seize the former president's assets, including the building at 40 Wall Street, if he is unable to pay.

Former President Donald Trump needs to arrange a $454 million bond to comply with a New York court ruling in less than a week, but the presumptive Republican presidential nominee says he can't find a company to put up the bond.

Trump's lawyers are asking an appeals court to stay the judgment, but the clock is ticking.

How did Trump come to owe the state of New York some $454 million?

Trump ordered to pay over $355M for fraudulent business practices in New York

This is the ruling that Judge Arthur Engoron issued last month , after finding that Donald, Eric and Donald Trump Jr., along with Trump Organization employees, engaged in a decade-long conspiracy to lie about the value of their assets.

In New York, if you make money by persistently committing fraud, you owe the ill-gotten portion back to the state. In this case, Judge Engoron determined that Donald Trump made over $350 million more than he should have if he'd been honest and when you add in interest, you get to $454 million.

Why does Trump have to come up with the money now?

Trump doesn't have to actually pay that money now, but he has to get a company to make a guarantee to the court that they will pay the money if he loses his appeal. That's the bond part.

But to get a bond, you have to put up assets, and in a court filing Monday Trump lawyers said they'd approached 30 companies but that getting a bond was a "practical impossibility," because they'd need a billion dollars in cash, which they don't have.

Trump unable to post $450M bond in New York fraud case, his lawyers say

They submitted an affidavit from an insurance executive who had testified at trial, and whom the trial judge had already discredited.

Trump says he's a billionaire. Why can't he just come up with the money himself?

Trump said during a deposition for this case, taken about a year ago, that he had plenty of cash. He said, "I believe we have substantially in excess of $400 million in cash ." And, he added, it's "going up very substantially every month."

News organizations have estimated that Trump actually has about $300 million in liquid assets — but he already had to set aside $100 million or so to put up a bond to pay the verdict in the E. Jean Carroll civil case . The rest of his money is largely tied up in buildings and golf courses, and while he could sell a property, that can't happen right away. Trump said Tuesday that would be a "fire sale," though he said many times during the trial he could always find a buyer to pay top dollar.

Jury orders Trump to pay $83 million for defaming columnist E. Jean Carroll

While Trump's political action committees have spent millions of dollars on his legal fees, they're unlikely to be of help to him in this case because of campaign finance laws .

Trump has accused the judge in the case of trying to take away his rights, posting on social media that any assets he may be forced to sell would be gone even if he ultimately wins his appeal.

That's a concern that any defendant could raise, whether they're liable for $450 or $450 million, says Adam Pollock, a former assistant attorney general in New York.

"But if you want to bond the appeal — stop enforcement of the judgment — you have to put up the full amount," he told Morning Edition . "That's what the law says. And that's a policy decision that Albany has made."

The deadline is Monday. What does Trump do if the appeals court doesn't rule his way?

He can appeal to New York's highest court and ask that court to stay the judgment. If they don't, he can ask a benefactor or he could try and stall some more until he comes into money from the upcoming sale of his social media company, or he could — though it has many disadvantages — declare bankruptcy.

But New York Attorney General Letitia James has been clear: If Trump doesn't pay, she will move to seize his assets.

"If he does not have funds to pay off the judgment, then we will seek judgment enforcement mechanisms in court," she said. "And we will ask the judge to seize his assets."

Trump's noncash assets run to $3 billion, Forbes estimates, so there's plenty of value there. The law limits the AG to seizing properties that were a part of the case, but there's about two dozen of those, everything from the Doral Golf Club to 40 Wall Street to Trump Tower. She's not limited to New York properties, though there are extra steps if she chooses to go out of state.

She could, in theory, send a sheriff or a marshal to enforce the judgment, and that brings on another legal process with many more opportunities for delay.

Can Trump be forced to pay up?

James can begin enforcement of the judgment immediately after the 30-day grace period expires next week, says Pollock. And there are several devices she can use to try to get him to pay.

For one, he says, she could serve Trump a restraining notice that would restrict his spending in other areas until he pays his bond.

"The restraining notice would say: 'Don't spend money, don't fill up your jet at the pump, until you pay the state of New York, or you'll be held in contempt of court,' " Pollock says. "And my impression is that ... Engoran, the judge here in New York, would be quick to hold him in contempt of court."

He says it's theoretically possible that James' could consider settling, especially if Trump were to write a check for something like $250 million. But short of that, he doesn't see any reason for her to proactively lower his bond, especially since she has the tools to go into banks and drain his accounts.

"The entire trial was effectively a roadmap to his financial assets," Pollock adds. "She can now send out a sheriff or a marshal of the city of New York to go walk into a financial institution holding what's known as an execution and empty his bank account short of $3,000, which is the statutory floor."

Pollock acknowledges that Trump has said he doesn't have $450 million in cash. But if he wants to stave off enforcement, "he needs to find a way to raise it."

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Creating awareness about Intellectual Property

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• Oct 25, 2021

Expiry Date of Copyright Assignment Contracts

An assignment is generally considered to be a transaction that results in the permanent transfer of copyrights. While this is a common belief, the Copyright Law in India provides for a default term of assignment when the assignment agreement does not specify a term. Section 19 of the Copyright Act of 1957 governs the mode of assignment of copyrights. Under Subsection 5 of this provision, it is stated that “ If the period of assignment is not stated, it shall be deemed to be 5 years from the date of assignment ”. Questions as to whether such default period is necessary and if yes, to whom and for what purpose must be deliberated upon. At the outset, the provision seems to be in favour of the author (usually the assignor) and against big house publishers/producers (usually the assignee).

Judicial position on Section 19(5) of the Copyright Act, 1957:

The copyright law, in India, is crisp and clear about the default duration of the assignment and it does not allow for any contradicting interpretations. The judiciary has tried to shed light on this provision’s application in specific scenarios. The following cases are key to understanding the said provision:

In the case of Dorling Kindersley (India) Pvt. V. Sanguine Technical Publishers, the Delhi High Court held that Section 19(5) must be read judiciously and not mechanically. It was highlighted that more weightage must be given to the intention of parties as against the clauses mentioned in the agreement. The Court, verbatim decided that

"The fair and meaningful reading of the agreement is essential in order to find out what the parties actually intended and whether they intended to assign the rights in perpetuity or for limited period and what is the indication of the term under the agreement. Thus, the judicious approach should be adopted while interpreting the agreement."

In Shemaroo Entertainment Ltd V. Amrit Sharma and Ors , the Delhi High Court placed importance on the words used in the contract to determine the intended term of an assignment rather than the strict application of Section 19(5). The court stated the following

"We think that the term of the copyright is defined by the wordings used as "absolutely", "worldwide" and similarly the royalty clause provides for payment of royalty for the period not exceeding the term of legally protectable copyright in the country. The usual term of copyright is for 60 years after the death of the author. Thus, if the royalty is intended to be paid for such period, coupled with the usage of the word "absolutely" and "worldwide", for prima facie view, it can be said that the said agreement is not the one which assigns the rights for limited period but assigns the rights absolutely."

In the case of Ilaiyaraja vs B.Narsimhasn , the Madras High Court mentioned that the act of receiving royalty past the 5 year default period is not sufficient to prove that the assignment is valid. It was clarified that assignment agreements must be written and signed to be enforceable. The court stated

“ …the plaintiff had received the royalty under the license agreement, it does not mean that the act of receiving the royalty would amount to ratifying the original contract. ”

In Saregama India Ltd. vs Suresh Jindal and Ors . , the Calcutta High Court highlighted that the absence of a time period cannot mean absolute assignment by default. In order to understand the intentions of the parties, one has to look at all clauses of the contract and not just the one defining the duration. The court mentioned that

“… an assignment does not automatically mean it is an absolute assignment. The intention of the parties with regard to the nature the extent of assignment is required to be ascertained from the agreement itself. If upon proper construction of the agreement it means that the assignment is for a limited period then it cannot be contended that simply because an assignment of copyright has been made given absolute ownership with regard to the copyright it has to be for an unlimited period. ”

In the case of M/S.Agi Music Sdn Bhd vs Ilaiyaraja , the Madras High Court specified that the law under Section 19(5) is a norm and that it has to be applied unless the contrary is evident. The implication of an assignment cannot be made just by virtue of receiving royalties. The court held that

“Any variation thereto would have to be the exception, and such exception is liable to be proved not merely by implication but conclusively. This is for the reason that the purpose of the prescription in Section 19 is the protection of rights of the assignor and this assumes paramount importance.”

Interpretation of Contracts:

Interpretation of contracts, in general, is governed by certain globally recognised principles. Guidelines such as interpreting technical terms in the context of the contract and awarding general meanings to words unless explicitly mentioned are some examples of such principles.

The study on how contracts should be interpreted is extensive and vast. No clear body of rules exists to govern the same consistently. The approaches towards the interpretation of contract are divided into objective, subjective, and literal approaches. Each of these differs in how much lenience the judge can take while interpreting the words in a contract.

In addition, the principles and approaches for interpreting contracts often contradict each other if applied simultaneously. Under such pretext, the application Section 19(5) must not depend completely on the interpretation of contracts.

A principle from the same body of guidelines states that the court must not accept the fact that there has been a mistake in the language of the contract easily since it is reviewed multiple times and then signed. If this principle is applied consistently, most cases would call for the application of Section 19(5) as the absence of the “term of contract” clause cannot be construed as a mistake.

Conclusion:

In a nutshell, the operation of Section 19(5) is usually favoured if the terms of the contract are not clear on the intention of the parties on the period of assignment. The courts have placed more weight on interpreting contracts to construe whether the parties had intended to assign the contract for a longer period. This approach seems to be mildly flawed as the purpose of Section 19(5) was to protect assignors from assignees who wish to take unfair advantage of perpetual assignment contracts. If there is an intention to continue the contract for a long period, the contract must mention the same clearly. In its absence, the court must apply Section 19(5) as a norm.

In the majority of cases mentioned above, the assignees are well-known producers with adequate access to lawyers and materials on contract drafting and vetting, therefore, a greater amount of responsibility must be placed on such corporate parties to ensure that the terms of the assignment contract are clear. A key point to ponder over is why such habituated producers would miss out on such an important clause in a copyright assignment agreement.

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Well researched and amazingly interpreted Article! Thank you for this.