Issues, Challenges and Opportunities in Oncology Production

 

We have 4 issues for discussion under this agenda.

 

Firstly, CEO is looking for costing of Oncology API as finished products so that we can set a price for selling it to other companies and also we can use as raw materials to be used in our Oncology Solid Facility (ROSF) for Oncology FG products. He suggested us yesterday to consider only variable cost. Could you please give us such costing for all available API under Oncology API Facility (ROAF)? Currently we have following 2 products in that facility for which we are interested to know the costing:

 

• Sorafenib Tosylate 3.0 Kg (SOT) 
• Sorafenib Tosylate INN 

 

Secondly, if we want to use our Oncology API as raw materials for Oncology FG products, do we need to conform any VAT formalities. If so, please take relevant actions in the regard and also please give us necessary training at warehouse end so that the operations get smoothen. Also how to proceed when we would go for selling those API to other companies, please?

 

Thirdly, we would like to sit with Pfizer Laboratories shortly where we would try to finalize the price for different QA/AC service that they already enjoyed. Please assign someone who can raise relevant financial concerns in that meeting. As soon as we know the meeting schedule we will let you know.

 

Finally, It is a gentle reminder that we are still looking for a regular source of item-wise cost information for our relevant available inventory. Please let us know when the information is ready so that we can plug in those to generate our monthly report of Inventory.

Responses: 

1. As per our records, the total quantity produced during 2020-21 FY, in the said facility is only 19Kg of different APIs as against Tk. 14.69 million as variable expenses. Thus, Variable Overhead Costing around Tk. 7.73 lac per KG as LOH excluding Material Cost is Tk. 0.90 lac per Kg. Both the items will bear almost the same variable cost (Tk. 863000/Kg) with a difference of Tk. 850 packaging cost.  

 

2. No such VAT formalities until we use resources internally through IOT. For external sales, VAT issues will be taken care of by us duly after the Price Declaration of the saleable product. We will just need a copy of Drug Annexure & Approved Price from FDA. You must sell the FG Item Code: 510050008 through a Depot from where Sales Order will be created like other general sales with DIMS in Legacy /Order Management in ERP. VAT Challans will be issues as usual where no additional training is necessary from us.

 

3. A person will be assigned from our end to join the meetings whenever you organize them with Pfizer.

 

4. ERP is a good regular source of information you are looking for, as long as our users enter data accurately therein. You can develop a report to pick the cost information from the system upon a discussion with the ERP Consultants               

Private international law with its international civil procedure

Private international law with its international civil procedure.

The competence.

- A judge is competent when the jurisdictional power to decide any matter before it.
Definition of competence.

matter of jurisdiction.

Next the value of the litigation.

- The value of the first-instance proceedings will reveal whether the judgment is subject to appeal or if there will be a further appeal possible.
→ For small claims, namely maximum 4000 euros, so the first and last spring not to appeal. In practice, there will be no cessation either.
 For all disputes concerning credit rights (personal actions), shared between Amtsgericht and TGI and Judge nearby
→ to 4000: Judge nearby.
→ Up to 10,000: District Court then beyond that is the High Court.

- To determine the amount, if any one claim, take the amount of the claim as expressed in principal in the last writings of the applicant.
- If no amount of demand, are "unspecified demands." Article 40 of the Civil Procedure Code provides that such requests are always subject to appeal. To avoid too much unencrypted requests, courts are severe about it = - An application for a symbolic euro ANY INTEREST & was considered a specified amount.
- If there are more applications, in general, we consider all applications that will be added to determine the level of competence.

Next Nature litigation.

- The types of disputes are contained in the COJ. The principle is that there is a common law jurisdiction normally competent unless a special provision gives the jurisdiction to special court / award.
- Two courts of general jurisdiction: TGI and CA.

TGI created in 58 to replace civilian courts broad jurisdiction. It aims to entertain any dispute unless the particular text excluded (eg personal or transferable shares if amount is less than 10K euros = -. District Court). If it has exclusive competence, it will rule until 4k euro in first and last resort, and call for more than 10k euros (exclusive materials: Article L211-4 and following State Ex people, real personal actions, litigation.. execution ...)

The President of TGI has a skill that is exercised for provisional and protective measures, and referred queries. In addition, skills on the bottom (commercial lease).

-- Court of Appeal. 35 in France. Responsible for all use of the 2nd degree. In very specific cases, the appeal will be filed before another judge of the 1st degree. Eg, certain decisions of the guardianship judge are challenged in the TGI.

The Court of Appeal can also find some new applications, and some geographically concentrated Appeal Court appeals against independent administrative authorities.

Community law has no legal basis to influence internal procedural rights

Retouching.

- After 1981, many decrees (over thirty) came to change the CODE OF CIVIL PROCEDURE. In addition to these one-off orders, there was the will to bring together committees to reflect the reforms. Today the procedure is not bad and is regularly subject to change. In any case all procedural questions are occupied by the debate on the reform of the judicial map.

Section 2 - Complementary national and international sources.

Jurisprudence.
- Not to be confused with judicial practice. It is abundant. No major turnarounds of Civil Procedure because it is hard to imagine that in a reformed without cease matter.

Practices and usages.
- Local customs, with styles and habits. Ex. Electronically.

Doctrine.
- Important role because it is a technical matter. 

International sources.
- Apply to internal or international disputes.

- In terms of the internal procedure, there are provisions of international law under Article 55 have superiority on the internal rules of procedures and who will therefore be applicable. Is basically the European Convention on Human Rights and Community law. Within the Convention, Article 6 gives the right to a fair trial, setting standards of procedure. According to part of the doctrine, the article 6 is the main source of the theory of action (the right of a person to apply to a judge). Community law has no legal basis to influence internal procedural rights, or very little. Here are the rules for disputes between borders.

Enactment of the CODE OF CIVIL PROCEDURE by order of 5 December 75

Old code of civil procedure.

- One of the 5 major Napoleonic code. Before the code, the general procedure of text dated 1667 (Colbert).

- The code 1806 has not managed to break away from tradition, and therefore appeared as old. In the 20th century, the need is urgent. In 1934, a reform commission CODE OF CIVIL PROCEDURE is created. His work lead to a law decree creating Judge to monitor the process (the ancestor of Justice of the State layout). From 58, the new provisions with the change of constitution. It is a decree of October 13, 65 which amended the proceedings before the High Court and anticipates the work that will lead to the CODE OF CIVIL PROCEDURE. Grand codification begins that will lead to CODE OF CIVIL PROCEDURE. There is a large code because responds to the challenges of the great codes.

- The challenge was to create a completely new code to cover the entire proceeding, without using its predecessors. It will take 18 years to complete.


- To reform the process, setting up a commission in 69 setting up under replay for commissions. Notice of the State Council.


- Enactment of the CODE OF CIVIL PROCEDURE by order of 5 December 75, which establishes the "CODE OF CIVIL PROCEDURE, which brings together previous decrees. "Composed of two books. Book I- Provisions common to all jurisdictions; Book II Provisions specific to each jurisdiction.



Problem, while in 1975 is not prepared, so CODE OF CIVIL PROCEDURE will later be enriched by other books.
- 1979 Book III decree on the appeal and the procedure before the Court of Cassation.
- 1981 Book IV Decree on arbitration and other materials.
- Project Book V- execution. Problem, until now everything is done through regulations. Or to enforcement can not be reformed by regulation, as the Constitution says it is legislative. 1981 left government, so this reform is not too up to date.


- 1991 reform out of the code: law reform in 1992 out of the code: decree on special seizures.



- Very good code, with structure, academically. Little brother of the Civil Code. It is a code that provides definitions, because the material has been radically reformed. Influence in this book the author Henri Motulsky, who is the instigator of the trial guidelines. Also this code also takes the practical requirements of litigants.

Law on Credit - banking - finance - insurance - real estate - rural law - construction - planning

Banking law is a branch of commercial law that deals with all the rules on banking transactions and those that perform as part of their professional activity. He intended to govern the activities on a regular basis by credit institutions.

The Right Credit is composed of the rules applicable to credit institutions, usually banks, credit operations and management of payment means, for companies and individuals.

Insurance law is the set of rules, laws and regulations governing insurance companies and relationships between insurers and insured. Insurance predict risk, and mitigate financial losses a loss or degradation.

Real estate law is the generic term that includes all legal texts of public law and private law concerning real property, as opposed to furniture.

This is part of the law of property, and relates both to the right of private property as the right heritage of public figures.

Its scope is very wide as it relates in particular the right to construction, planning law, law of mortgages ...

Commercial paper are documents issued by a creditor to a debtor giving order in writing via a third party to pay a debt to a beneficiary due. It is one of the bills of exchange or promissory note, among others. Commercial paper are useful means of payment to companies under business with payment deadlines. This allows secure and formalize the terms of payment.

Rural law is traditionally the set of rules for farming and those who practice it. He oversees and supports the evolution of French agriculture in the European legal framework designed by the common agricultural policy.

The place of civil law in private law - The law of exception.

A) The place of civil law in private law

Originally civil law almost overpowered instead of private law, but we shall see, gradually the civil law is going to have some of its branches will detach. But civil law remains what is called common law. The rules of the civil law will apply in priority. New needs, new relationships will appear and we will need to specialize in disciplines. Exception will be called the law law other than the Civil Law.

Example: in our society, consumption has a key role, then in 2000 the Consumer Code was created ; it is a branch that broke off of civil law. The trunk (civil law), this will be the common law, and branches the exception of Law.

1) The common law.

Civil law (common law) includes all the rules on the privacy of individuals in their personal relationships, these relationships they can have as much on the family level as on the professional level. And in civil law, we will find several types of law: the law of persons, family law, contract law, property law, the law of matrimonial property regimes. The common law does not affect any special rules.


The right of persons: when one is born, it has acquired legal personality which we were allocated a first name and a surname ...

Family law: one is interested in relationships with each other, such as with marriage (age criteria ... of gender differentiation).

2) The law of exception.

Commercial law will determine the status of merchants, business activity, the relationship between traders. In the Civil Code there is a part that deals with contracts between individuals but, in trade, we have other needs (speed, certainty ...) and the civil code does not provide the trader. Gradually, they built their own rules which became detached from the civil law term to form an autonomous code, hence the birth of commercial law. Inside this commercial, other rights have emerged. The changes in society have made the creation of necessary

new branches of law including right here with the air, maritime, and it goes to law firms in difficulties which have also seconded civil law into a law of exception. Rural is a right that includes special rules that derogate from ordinary law, particularly when referring to sharecropping or tenant farming. Employment law is a law of exception, labor relations have developed and with them the need to create special rules which derogate from ordinary law (dismissal, talks). Example: criminal law and private international law.

Gradually the exception of law encroaches on common law and takes more and more space. It must be remembered that the place of civil law is predominant in private law; Indeed, the civil law applies in principle to govern matters of private law.

Board of Governance is resonsible for operations with Essential Business Assets

In Spain, the new law is approved. Law 31/2014, of 3 December, approving the Capital Companies Act (LSC) for the improvement of corporate governance changes, indicating that it is for the general meeting deliberate and resolve on the acquisition, disposal or the contribution to society other essential assets. The essential character of the asset is presumed when the amount of the transaction exceeds 25% of the value of the assets listed in the latest approved balance sheet.

The new power of the General Meeting, ie decide on "the acquisition, disposal or contribution to another company of essential assets" requires a distinction in the legal business conducted by the board (usually acquisition / disposal of assets) if it is "essential" assets -Competence of the General- Board or administration-organ -Competence without the legislature required that assessed so it is an "essential asset." Only establishes a presumption, but does not clarify who is competent to decide on the character of "essential" asset, or whether the possible lack of agreement affects third parties.
Operations comprising

What is to be in new Law:

• Acquisition of core assets, provided that the transferor is a company,
• Disposal of key assets, provided that the purchaser is another company, and
• Essential contribution to another company assets.

Presumption of core assets

The Act does not define the essential assets only establishes a presumption about the essential nature of the assets according to their economic value, "the essential character of the asset is presumed when the amount of the transaction exceeds twenty five percent of the value of the assets listed in the last balance sheet approved "

It is a rebuttable presumption (rebutted), so that may have assets exceeding 25% and non-essential, and vice versa, assets value less than 25% and yet are essential.

The presumption means that:

- If the asset sold or acquired exceeds 25%, it will be the test administrator in case of complaint, that there is an essential asset (eg a society that alienates property whose value exceeds 25% of the value of assets, but whose purpose is precisely the sale of the properties that form part of its assets, in the case of an operation so normal course of business, of competence of the governing body).

- However, if the asset disposed does not exceed 25%, but is considered by the shareholders or creditors, which is an essential for society active must be them claiming responsibility the management body who prove the essential character of the asset (eg society that alienates a patent or an administrative concession, whose value does not exceed 25% of assets, but without which it can not develop the social object).

If you have questions about whether a purchase or sale is not "essential", avoid risks and seek authorization from partners to do it. For this purpose, convene a meeting at which he is authorized to do the operation and the conditions of this (price of purchase or sale, term to be done, payment) are established. If it does not and that are essential assets, members can be held accountable (for example, if the operation harms society).

The bankruptcy proceedings are reduced by 22% in the first quarter

The number of bankruptcy proceedings fell by 22% between January and April 2016 compared to the same period last year, a development which is attributed to increased preconcursos and court settlements, while business solutions rose 4% .

This follows from the 'Study on Contests and Solutions' by the company Informa D & B, which stands at 1,572 bankruptcy proceedings occurred during the first quarter of this year and 10,004 solutions.

Specifically, companies in bankruptcy add 11,192 workers and billed about 1,900 million euros per year, 31% less than those that were affected by this situation between January and April 2015. Meanwhile, the solutions reverberated in 34,704 people and a turnover of 9,300 million euros, above the 6.600 billion euros last year.

Month of April

Only in April, Informa D & B number in 355 contests creditors, 25% less than in the same month last year and the lowest figure of the whole exercise. According to the Director of Studies of Informa D & B, Nathalie Gianese, this development "can partly be explained by the increase precursors processes and extra-judicial agreements, which are not listed in the bankruptcy statistics." In contrast, the 1,712 solutions represent a 2% more than a year ago.

The study also suggests that micro-enterprises were the most affected by the bankruptcy proceedings in April, representing almost 82% of the total, while small enterprises accounted for about 16% of cases, the median about 2% and large only 0.6%.

By region, Catalonia heads the number of processes both in April (81) as in the first quarter of 2016 (316), although it is also the region that reduces their numbers in absolute value since January, subtracting 117.

It is followed by Valencia (254 in four months and 54 in April) and the Community of Madrid (226 and 46 respectively). Only four communities increased the number of competitions over last year, highlighting the Canary Islands (+39) and Cantabria (+13).

As for solutions, Madrid, Andalusia and Valencia led the quarterly and monthly statistics, processes 2,413, 1,292 and 1,249 closures solutions, respectively. However, the Madrid region was experienced a greater absolute increase (+298) while Catalonia was the biggest decliners solutions (-148).
 

By sector

As for the different sectors, construction was the most processes had (433) in the first quarter. Along with Trade (344) and business services (198) account for 62% of all competitions, it concentrates 62% of the solutions, con2.552, 2,056 and 1,566 respectively.

The same three sectors were the hardest hit in April, with 108 and 460 solutions contests construction, trade 78 and 355, 46 and 268 and business services.

However, the construction was also the sector that reduced both contests as solutions, 179 and 132 processes less, respectively. In fact, the contests were increased only in the extraction industries (+ 60%) and healthcare (+ 14%) during the first four months of the year, while solutions grew only in Energy (+ 82%) and Administration ( + 50%).

Do you want to increase Capital against reserves or profits of the enterprise

Do you have to increase the share capital of the company from reserves ?. Note that for this, a General Meeting must have passed a balance within the six months prior to the agreement of capital increase and that it must be verified by the auditor of the company or by an auditor appointed by the Company Register at the request of administrators, if society were not required to be audited.

As you know if you want to increase the share capital of the company, it can be achieved by creating new shares or issuing new shares or by increasing the nominal value of the existing ones. In both cases, the capital may be increased by means of new cash contributions in kind or social heritage, including the provision of credits against the company or against profits or reserves already incorporated into it last approved balance sheet.

A capital is a form of business financing is to increase the equity of a company increasing its capital.

This funding can be obtained with the existing shareholders of the company with the contribution of new capital, or sacrificing the remuneration of shareholders, so that the expansion is done against reserves or undistributed earnings allocated to reserves.

As it regards the initiative of the enlargement, the Board of Directors who normally corresponds propose to the shareholders' meeting, though, by law, any shareholder holding more than 5% property may request that a meeting be convened and propose their own project alternatives, including increase capital.

Capital increase against reserves or profits

It is to use available reserves as share premium, legal reserve and undistributed earnings allocated to reserves. The realization of a capital increase of this type involves making an accounting entry consisting of a transfer of the reserve account or benefit to social capital.

With the capital increase against reserves, the amount of capital and reserves remains the same, therefore any quantitative financial change does not occur. Instead, it means a qualitative change because society happens to have availability of their reservations to not be available for having transferred to the capital account.

To capitalize reserves the requirement that they are freely available must also be met. The law sets limits freely available, stating that:

The general meeting resolved on the implementation of the profit according to the approved balance sheet.Once as are provided by law or statute, they may only be distributed dividends against profit for the year or unrestricted reserves if the value of equity is not or, as a result of the distribution, will not be less than capital stock. For this purpose, the benefits recognized directly in equity will not be subject to distribution, directly or indirectly.

If there are losses from previous years that cause the value of the net assets of the company is less than the amount of share capital, the proceeds will be used to offset these losses.

Any distribution of benefits is also prohibited unless the amount of available reserves is at least equal to the amount of research and development expenditures appearing on the balance sheet.

When the capital increase is made against reserves, may be used for this purpose available reserves, reserves for premium of shares or share issue and the legal reserve in full, if society were limited liability or in the amount exceeding 10% of the increased share capital, if society was anonymous.
Balance and auditing.